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Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.
Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorb™ BVS | Experimental | Subjects receiving Absorb™ BVS |
|
| XIENCE PRIME®/XIENCE Xpedition™ | Active Comparator | Subjects receiving XIENCE PRIME®/XIENCE Xpedition™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XIENCE PRIME®/XIENCE Xpedition™ | Device | Subjects receiving XIENCE PRIME®/XIENCE Xpedition™ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Any Death/Any MI/Revascularization (DMR) |
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Inclusion Criteria:
Subject must be at least 20 years of age.
Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
Female subject of childbearing potential must not be pregnant* at the index procedure and does not plan pregnancy for up to 1 year following the index procedure.
* Except for non-pregnancy is apparent, negative pregnancy result within 7 days prior to the index procedure is required.
Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure
Exclusion Criteria:
Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
Subject has known hypersensitivity or contraindication to device material and its degredants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure
Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary).
The target vessel was treated by PCI within 12 months.
Prior PCI within the non-target vessel is acceptable if performed anytime > 30 days before the index procedure or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
Subject requires future staged PCI either in target or non target vessels.
Subject has a malignancy that is not in remission.
Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.,). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease.
Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin or any other agent for any reason).
Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
Subject has a documented or suspected cirrhosis of Child-Pugh ≥ Class B.
Subject has known renal insufficiency;
Subject is high risk of bleeding, or difficult to have appropriate treatment;
Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
Subject has life expectancy < 3 year.
Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g. subordinate hospital staff or sponsor staff) or subject is unable to read or write.
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Kimura, MD | Kyoto University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya Daini Red Cross Hospital | Nagoya | Aichi-ken | 466-8650 | Japan | ||
| Fujita Health University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33893022 | Derived | Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21. | |
| 32213737 |
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The target sample size was approximately 400 subjects (266 in the Absorb arm and 134 in the XIENCE arm) enrolled in approximately 40 investigational sites in Japan. First subject was enrolled on April 27, 2013 and the last subject completed 5-year follow-up on January 16, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Absorb BVS | Subjects receiving Absorb BVS |
| FG001 | XIENCE PRIME/XIENCE Xpedition | Subjects receiving XIENCE PRIME/XIENCE Xpedition |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Absorb™ BVS | Device | Subjects receiving Absorb™ BVS |
|
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization |
| 1 month |
| Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 6 months |
| Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 1 year |
| Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 2 years |
| Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 3 years |
| Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 4 years |
| Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | 5 years |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 1 month |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 6 months |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 1 year |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 2 years |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 3 years |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 4 years |
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 5 years |
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 1 month |
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 6 months |
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 2 years |
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 3 years |
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 4 years |
| Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 5 years |
| Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 1 month |
| Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 6 months |
| Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 1 year |
| Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 2 years |
| Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 3 years |
| Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 4 years |
| Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 5 years |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 1 month |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 6 months |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 1 year |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 2 years |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 3 years |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 4 years |
| Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 5 years |
| Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 1 month |
| Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 6 months |
| Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 1 year |
| Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 2 years |
| Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 3 years |
| Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 4 years |
| Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 5 years |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 1 month |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 6 months |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 1 year |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 2 years |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 3 years |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 4 years |
| Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | 5 years |
| Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| 1 month |
| Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| 6 months |
| Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| 1 year |
| Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| 2 years |
| Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| 3 years |
| Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| 4 years |
| Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| 5 years |
| Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 1 month |
| Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 6 months |
| Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 1 year |
| Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 2 years |
| Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 3 years |
| Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 4 years |
| Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 5 years |
| Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 1 month |
| Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 6 months |
| Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 1 year |
| Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 2 years |
| Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 3 years |
| Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 4 years |
| Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | 5 years |
| Number of Participants With Target Vessel MI (TV-MI) | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Target Vessel MI (TV-MI) | 1 month |
| Number of Participants With Target Vessel MI (TV-MI) | 6 months |
| Number of Participants With Target Vessel MI (TV-MI) | 1 year |
| Number of Participants With Target Vessel MI (TV-MI) | 2 years |
| Number of Participants With Target Vessel MI (TV-MI) | 3 years |
| Number of Participants With Target Vessel MI (TV-MI) | 4 years |
| Number of Participants With Target Vessel MI (TV-MI) | 5 years |
| Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Acute (≤ 1 day) |
| Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Subacute (>1 - 30 days) |
| Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Late (31 - 365 days) |
| Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Very Late (366 - 730 days) |
| Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Very Late (731 - 1095 days) |
| Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Very Late (1096 - 1460 days) |
| Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Very Late (1461 - 1825 days) |
| In-segment Late Loss (Non-inferiority) | 13 months |
| Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG) | Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure. | 2 years |
| Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation | Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure. Absolute Vaso dilatation = Post Nitroglycerin (NTG) - Pre Nitroglycerin (NTG) | 2 years |
| Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG) | Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure. | 2 years |
| Number of Participants With Cardiac Death, All MI, ID-TLR (MACE) | 5 years |
| Number of Participants With Not Ischemia-driven TLR (NID-TLR) | 5 years |
| Number of Participants With Non-Target Vessel MI (NTV-MI) | 5 years |
| Toyoake-shi |
| Aichi-ken |
| 470-1192 |
| Japan |
| ShinTokyo | Matsudo-shi | Chiba | 270-2232 | Japan |
| Kokura Memorial Hospital | Kitakyushu-shi | Fukuoka | 802-8555 | Japan |
| Kurume University | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Shinkoga Hospital | Kurume-shi | Fukuoka | 830-8577 | Japan |
| Hanaoka Seishu Memorial Cardiovascular Clinic | Sapporo | Hokkaido | 062-0003 | Japan |
| Kyoto University | Kyoto | Honshu | 606-8507 | Japan |
| Kansairosai Hospital | Amagasaki-shi | Hyōgo | 660-8511 | Japan |
| Kobe University | Kobe | Hyōgo | 650-0017 | Japan |
| Tsukuba Medical Center | Tsukuba | Ibaraki | 305-8558 | Japan |
| Iwate Medical University | Morioka | Iwate | 020-8505 | Japan |
| Tokai University | Isehara-shi | Kanagawa | 259-1193 | Japan |
| Shonankamakura General Hospital | Kamakura-shi | Kanagawa | 247-8533 | Japan |
| Kanto Rosai Hospital | Kawasaki-shi | Kanagawa | 211-8510 | Japan |
| Saiseikai Yokohamashi Tobu Hospital | Yokohama | Kanagawa | 230-8765 | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | Kumamoto | 861-4193 | Japan |
| Miyazak Medical Association Hospital | Miyazaki | Miyazaki | 880-0834 | Japan |
| Tenri Hospital | Tenri-shi | Nara | 632-8552 | Japan |
| Kurashiki Central Hospital | Kurashiki-shi | Okayama-ken | 710-8602 | Japan |
| Sakurabashi Watanabe Hospital | Osaka | Osaka | 530-0001 | Japan |
| Osaka University | Suita-shi | Osaka | 565-0871 | Japan |
| The National Cerebral and Cardiovascular Center | Suita-shi | Osaka | 565-8565 | Japan |
| Saitama Medical Center Jichi Medical University | Saitama-shi | Saitama | 330-8503 | Japan |
| Saitama Sekishinkai | Sayama-shi | Saitama | 350-1323 | Japan |
| Juntendo University | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| University of Tokyo | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Mitsui Memorial Museum | Chiyoda-ku | Tokyo | 101-8643 | Japan |
| Sakakibara Memorial Hospital | Fuchu-shi | Tokyo | 183-0003 | Japan |
| Teikyo University | Itabashi-Ku | Tokyo | 173-8606 | Japan |
| Toho University Ohashi Medical Center | Meguro-ku | Tokyo | 153-8515 | Japan |
| The Cardiovascular Institute Hospital | Minato-Ku | Tokyo | 106-0031 | Japan |
| Showa University Hospital | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Tokyo Women's Medical University | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Dokkyo University | Tochigi | Utsunomiya | 321-0293 | Japan |
| Wakayama Medical University Hospital | Kimiidera | Wakayama | 641-8509 | Japan |
| Yamaguchi University | Ube-shi | Yamaguchi | 755-8505 | Japan |
| Tokushima Red Cross Hospital | Tokushima | 773-8502 | Japan |
| Abbott Vascular Japan Co., Ltd. | Tokyo | 108-6304 | Japan |
| Derived |
| Kozuma K, Tanabe K, Hamazaki Y, Okamura T, Ando J, Ikari Y, Nakagawa Y, Kusano H, Ediebah D, Kimura T; ABSORB Japan Investigators. Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent - A Randomized Comparison Through 5 Years in Japan. Circ J. 2020 Apr 24;84(5):733-741. doi: 10.1253/circj.CJ-19-1184. Epub 2020 Mar 26. |
| 31918929 | Derived | Onuma Y, Honda Y, Asano T, Shiomi H, Kozuma K, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Hanaoka KI, Tanabe K, Okada K, Kitahara H, Ono M, Kusano H, Rapoza R, Simonton C, Popma JJ, Stone GW, Fitzgerald PJ, Serruys PW, Kimura T. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years. JACC Cardiovasc Interv. 2020 Jan 13;13(1):116-127. doi: 10.1016/j.jcin.2019.09.047. |
| 31561250 | Derived | Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101. |
| 29622143 | Derived | Okada K, Honda Y, Kitahara H, Otagiri K, Tanaka S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Kimura T; ABSORB Japan Investigators. Bioresorbable Scaffold for Treatment of Coronary Artery Lesions: Intravascular Ultrasound Results From the ABSORB Japan Trial. JACC Cardiovasc Interv. 2018 Apr 9;11(7):648-661. doi: 10.1016/j.jcin.2017.11.034. |
| 29089314 | Derived | Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31. |
| 26825231 | Derived | Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27. |
| 26330419 | Derived | Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Absorb BVS | Subjects receiving Absorb BVS |
| BG001 | XIENCE PRIME/XIENCE Xpedition | Subjects receiving XIENCE PRIME/XIENCE Xpedition |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Death/Any MI/Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
|
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| Secondary | Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
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| Secondary | Number of Participants With Cardiac Death/All MI | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
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| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
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| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
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| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
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| Secondary | Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
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| Secondary | Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
|
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| Secondary | Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
|
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| Secondary | Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
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| Secondary | Number of Participants With Ischemia-driven TVR (ID-TVR) | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
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| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
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| Secondary | Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
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| Secondary | Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
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| Secondary | Number of Participants With Ischemia-driven Revascularization (ID-TLR) | A revascularization is considered ischemia-driven if associated with any of the following:
| ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
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| Secondary | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
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| Secondary | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
|
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| Secondary | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
|
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| Secondary | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
|
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| Secondary | Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) | Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
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| Secondary | Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
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| Secondary | Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
|
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| Secondary | Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
|
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| Secondary | Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI)) | - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel MI (TV-MI) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel MI (TV-MI) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 month |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel MI (TV-MI) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel MI (TV-MI) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 1 year |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel MI (TV-MI) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 2 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel MI (TV-MI) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 3 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel MI (TV-MI) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 4 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel MI (TV-MI) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event. | Posted | Count of Participants | Participants | Acute (≤ 1 day) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event. | Posted | Count of Participants | Participants | Subacute (>1 - 30 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event. | Posted | Count of Participants | Participants | Late (31 - 365 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event. | Posted | Count of Participants | Participants | Very Late (366 - 730 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event. | Posted | Count of Participants | Participants | Very Late (731 - 1095 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event. | Posted | Count of Participants | Participants | Very Late (1096 - 1460 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent/Scaffold Thrombosis | ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings:
| Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event. | Posted | Count of Participants | Participants | Very Late (1461 - 1825 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | In-segment Late Loss (Non-inferiority) | Full Analysis Set Population | Posted | Count of Participants | Participants | 13 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG) | Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure. | Full Analysis Set Population | Posted | Mean | Standard Deviation | millimetre | 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation | Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure. Absolute Vaso dilatation = Post Nitroglycerin (NTG) - Pre Nitroglycerin (NTG) | Full Analysis Set Population | Posted | Mean | Standard Deviation | millimetre | 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG) | Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure. | Full Analysis Set Population | Posted | Mean | Standard Deviation | millimetre | 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death, All MI, ID-TLR (MACE) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Not Ischemia-driven TLR (NID-TLR) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Non-Target Vessel MI (NTV-MI) | ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | Count of Participants | Participants | 5 years |
|
|
5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Absorb BVS | Subjects receiving Absorb BVS | 15 | 254 | 127 | 266 | 217 | 266 |
| EG001 | XIENCE PRIME/XIENCE Xpedition | Subjects receiving XIENCE PRIME/XIENCE Xpedition | 4 | 127 | 61 | 134 | 110 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| AORTIC VALVE STENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT CORONARY ARTERY RESTENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTRACARDIAC THROMBUS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| POSTINFARCTION ANGINA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRINZMETAL ANGINA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SINUS ARREST | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUDDEN HEARING LOSS | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGLE CLOSURE GLAUCOMA | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORNEAL DEGENERATION | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETIC RETINOPATHY | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EYELID PTOSIS | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MACULAR FIBROSIS | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VITREOUS HAEMORRHAGE | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COLONIC POLYP | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERIODONTITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RECTAL POLYP | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DISUSE SYNDROME | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THROMBOSIS IN DEVICE | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BURSITIS INFECTIVE | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETIC GANGRENE | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| COMMINUTED FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| MULTIPLE FRACTURES | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| SUBCUTANEOUS HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD GLUCOSE ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM T WAVE PEAKED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CERVICAL SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL LIGAMENT OSSIFICATION | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLESTEATOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| COLON NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC CANCER STAGE 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LIP AND/OR ORAL CAVITY CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| SMALL CELL LUNG CANCER STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| SMALL INTESTINE CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CERVICAL MYELOPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CERVICOBRACHIAL SYNDROME | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTRACRANIAL HYPOTENSION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| POST HERPETIC NEURALGIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THALAMUS HAEMORRHAGE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CYSTITIS HAEMORRHAGIC | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUBCUTANEOUS EMPHYSEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| AORTIC RUPTURE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTERIOVENOUS FISTULA | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EXTREMITY NECROSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| REPERFUSION INJURY | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUBCLAVIAN ARTERY STENOSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| AORTIC VALVE STENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTERIOSPASM CORONARY | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BUNDLE BRANCH BLOCK LEFT | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISSECTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY EMBOLISM | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT CORONARY ARTERY RESTENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTRACARDIAC THROMBUS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| POSTINFARCTION ANGINA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRINZMETAL ANGINA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SINUS ARREST | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUDDEN HEARING LOSS | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VERTIGO POSITIONAL | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PITUITARY HAEMORRHAGE | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| STEROID WITHDRAWAL SYNDROME | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| AGE-RELATED MACULAR DEGENERATION | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGLE CLOSURE GLAUCOMA | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONJUNCTIVAL HAEMORRHAGE | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS ALLERGIC | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORNEAL DEGENERATION | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETIC RETINOPATHY | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EYELID PTOSIS | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MACULAR FIBROSIS | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MACULAR OEDEMA | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| POSTERIOR CAPSULE OPACIFICATION | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RETINAL VEIN OCCLUSION | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VISUAL IMPAIRMENT | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VITREOUS HAEMORRHAGE | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL WALL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHEILITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COLONIC POLYP | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DENTAL CARIES | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIVERTICULUM INTESTINAL | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRITIS ATROPHIC | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MOUTH HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PAROTID GLAND ENLARGEMENT | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERIODONTITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RECTAL POLYP | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ADVERSE DRUG REACTION | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATHETER SITE HAEMATOMA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATHETER SITE HAEMORRHAGE | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATHETER SITE PAIN | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATHETER SITE RASH | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DISUSE SYNDROME | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INJECTION SITE PHLEBITIS | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THROMBOSIS IN DEVICE | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLANGITIS ACUTE | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANAPHYLACTOID REACTION | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONTRAST MEDIA ALLERGY | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BURSITIS INFECTIVE | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETIC GANGRENE | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| HORDEOLUM | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PYODERMA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| TINEA INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| ANAEMIA POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ANASTOMOTIC LEAK | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| COMMINUTED FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CONTRAST MEDIA REACTION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| MULTIPLE FRACTURES | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| OPEN WOUND | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| SUBCUTANEOUS HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| VASCULAR ACCESS COMPLICATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE MB INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD GLUCOSE ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC ENZYMES INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM ST SEGMENT ELEVATION | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM T WAVE PEAKED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| OCCULT BLOOD POSITIVE | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TROPONIN I INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| METABOLIC ALKALOSIS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CERVICAL SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERIARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SERONEGATIVE ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL LIGAMENT OSSIFICATION | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| ADRENAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLESTEATOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| COLON NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC CANCER STAGE 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROINTESTINAL STROMAL TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LIP AND/OR ORAL CAVITY CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| SMALL CELL LUNG CANCER STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| SMALL INTESTINE CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CERVICAL MYELOPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CERVICOBRACHIAL SYNDROME | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLINERGIC SYNDROME | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIZZINESS POSTURAL | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERTENSIVE ENCEPHALOPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTERCOSTAL NEURALGIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTRACRANIAL HYPOTENSION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| POST HERPETIC NEURALGIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TENSION HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THALAMUS HAEMORRHAGE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VOCAL CORD PARALYSIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEAD BANGING | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NEUROSIS | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CALCULUS URINARY | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| CYSTITIS HAEMORRHAGIC | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| CYSTITIS NONINFECTIVE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| DYSURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| POLLAKIURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| RENAL FAILURE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| URATE NEPHROPATHY | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| HAEMATOSPERMIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| UTERINE PROLAPSE | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| BRONCHIECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| NASAL MUCOSAL DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PAINFUL RESPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| RESPIRATORY ALKALOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| RESPIRATORY TRACT HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| DIABETIC BULLOSIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| ECZEMA ASTEATOTIC | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| ECZEMA NUMMULAR | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| HAEMORRHAGE SUBCUTANEOUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| HYPERKERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| PARAPSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| PRURIGO | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| SENILE PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| SOLAR DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| SUBCUTANEOUS EMPHYSEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| TOOTH EXTRACTION | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| AORTIC ANEURYSM | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| AORTIC RUPTURE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| ARTERIOVENOUS FISTULA | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| EXTRAVASATION BLOOD | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| EXTREMITY NECROSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| PERIPHERAL COLDNESS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| REPERFUSION INJURY | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| SUBCLAVIAN ARTERY STENOSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| VARICOPHLEBITIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| VENOUS INSUFFICIENCY | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hajime Kusano | Abbott Vascular | 408-845-1626 | +1 | hajime.kusano@av.abbott.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D023903 | Coronary Restenosis |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
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