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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12608000582358 |
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The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Elementâ„¢ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.
This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).
The wide-spread use of DES has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008).
During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis.
The main study is the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212. The clinical protocol includes two companion sub-trials with smaller vessels (PLATINUM SV) and longer lesions (PLATINUM LL) plus a Pharmacokinetics sub-trial (PLATINUM PK). The three sub-trials are registered under separate NCT numbers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROMUS | Active Comparator | Patients who received the PROMUS (XIENCE V) Everolimus-Eluting Coronary Stent |
|
| PROMUS Element | Experimental | Patients who received the PROMUSâ„¢ Element Everolimus-Eluting Coronary Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROMUS Coronary Stent System | Device | PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | 12-month post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | 30 days |
| Target Lesion Failure (TLF) |
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Inclusion Criteria:
Angiographic Inclusion Criteria (visual estimate):
- Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) >=2.50 mm and <=4.25 mm. Target lesion length must measure (by visual estimate) <=24 mm. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.
Exclusion Criteria:
Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)
Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.
Patients are excluded if any of the following criteria are met at time of the index procedure.
If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure.
Troponin >1× ULN with at least one of the following.
Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling/randomizing the patient.
Patient has received an organ transplant or is on a waiting list for an organ transplant
Patient is receiving or scheduled to receive chemotherapy within 30 days before or after index procedure
Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
Patient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome
Patient has platelet count <100,000 cells/mm3 or >700,000 cells/mm3
Patient has white blood cell (WBC) count <3,000 cells/mm3
Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
Patient is on dialysis or has known renal insufficiency (ie, estimated creatinine clearance <50 ml/min by the Cockcroft Gault formula, or [(140-age)*lean body weight (in kg)]/[plasma creatinine (mg/dl)*72])
Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure
Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to index procedure
Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index procedure
Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
Planned PCI or CABG after index procedure
Patient previously treated at any time with coronary intravascular brachytherapy
Patient has a known allergy to the study stent system or protocol-required concomitant medications (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
Patient has active peptic ulcer or active gastrointestinal (GI) bleeding
Patient has one of the following.
Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
Patient intends to participate in another investigational drug or device clinical trial within 12 months after index procedure
Patient with known intention to procreate within 12 months after index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)
Patient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
Patient has more than 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure
Angiographic Exclusion Criteria (visual estimate):
Target lesion meets any of the following criteria:
Non-target lesion to be treated during the index procedure meets any of the following criteria:
Patient has unprotected left main coronary artery disease (>50% diameter stenosis)
Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
Patient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required
Patient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent.
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| Name | Affiliation | Role |
|---|---|---|
| Peter M Maurer, MPH | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center Princeton | Birmingham | Alabama | 35211 | United States | ||
| Banner Good Samaritan Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21470815 | Result | Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Allocco DJ, Dawkins KD; PLATINUM Trial Investigators. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial. J Am Coll Cardiol. 2011 Apr 19;57(16):1700-8. doi: 10.1016/j.jacc.2011.02.016. Epub 2011 Apr 4. | |
| 29217001 |
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The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
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Enrollment of 1,532 patients was planned; 1,530 patients (762 PROMUS and 768 PROMUS Element) were enrolled and randomized at 132 clinical sites from January 27, 2009 to September 4, 2009. Of these, 788 patients were from the USA, 562 from Europe, 124 from Japan, and 56 from the Asia-Pacific region excluding Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | PROMUS | Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) |
| FG001 | PROMUS Element | Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| PROMUS Element Coronary Stent System | Device | PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS [XIENCE V] stent). |
|
| Aspirin | Drug | Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter. |
|
| Thienopyridine | Drug | Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant. |
|
|
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
| 6 months |
| Target Lesion Failure (TLF) | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | 12 months |
| Target Vessel Failure (TVF) | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. | 30 days |
| Target Vessel Failure (TVF) | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. | 6 months |
| Target Vessel Failure (TVF) | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. | 12 months |
| Myocardial Infarction (MI) Related to the Target Vessel | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | 30 days |
| Myocardial Infarction (MI) Related to the Target Vessel | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | 6 months |
| Myocardial Infarction (MI) Related to the Target Vessel | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | 12 months |
| All Cause Mortality | 30 days |
| All Cause Mortality | 6 months |
| All Cause Mortality | 12 months |
| Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded | 30 days |
| Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded | 6 months |
| Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded | 12 months |
| Non-cardiac Death | Defined as a death not due to cardiac causes (see definition of cardiac death above) | 30 Days |
| Non-cardiac Death | Defined as a death not due to cardiac causes (see definition of cardiac death above) | 6 Months |
| Non-cardiac Death | Defined as a death not due to cardiac causes (see definition of cardiac death above) | 12 months |
| Cardiac Death or Myocardial Infarction (MI) | Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above | 30 days |
| Cardiac Death or Myocardial Infarction (MI) | Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above | 6 months |
| Cardiac Death or Myocardial Infarction (MI) | Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above | 12 months |
| All Death or Myocardial Infarction (MI) | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | 30 days |
| All Death or Myocardial Infarction (MI) | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | 6 months |
| All Death or Myocardial Infarction (MI) | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | 12 months |
| Target Lesion Revascularization (TLR) | Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. | 30 days |
| Target Lesion Revascularization (TLR) | TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. | 6 months |
| Target Lesion Revascularization (TLR) | TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. | 12 months |
| Target Vessel Revascularization (TVR) | Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. | 30 days |
| Target Vessel Revascularization (TVR) | TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. | 6 months |
| Target Vessel Revascularization (TVR) | TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. | 12 months |
| Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). | 24 hours |
| Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). | >24 hr-30 days |
| Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). | >30 days-1 year |
| Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | See above for definitions of MI and TVR | 30 days |
| Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | See above for definitions of MI and TVR. | 6 months |
| Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | See above for definitions of MI and TVR. | 12 months |
| Clinical Procedural Success | Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death | In hospital |
| Acute Technical Success | Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent | Acute-At time of index procedure |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Bakersfield Memorial Hospital | Bakersfield | California | 93301 | United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| Good Samaritan Hospital | Los Angeles | California | 90017 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| University of California San Diego | San Diego | California | 92103 | United States |
| Alvarado Hospital | San Diego | California | 92120 | United States |
| South Denver Cardiology Associates, PC | Littleton | Colorado | 80120 | United States |
| Medical Center of the Rockies (Loveland) | Loveland | Colorado | 80538 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| MediQuest Research Group Inc. at Munroe Regional Medical Center | Ocala | Florida | 34471 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| Medical Center of Central Georgia | Macon | Georgia | 31201 | United States |
| Southern Illinois University Memorial Medical Center | Springfield | Illinois | 62702 | United States |
| St. John's Hospital | Springfield | Illinois | 62769 | United States |
| Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 | United States |
| St. Vincent's Hospital | Indianapolis | Indiana | 46260 | United States |
| Mercy Hospital Medical Center | Des Moines | Iowa | 50314 | United States |
| Jewish Hospital and St. Mary's Healthcare | Louisville | Kentucky | 40202 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | United States |
| Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| St. Mary's Duluth Clinic Regional Heart Center | Duluth | Minnesota | 55805 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic Foundation | Rochester | Minnesota | 55905 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| St. Luke's Hospital / Mid America Heart Institute | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | United States |
| Cooper Hospital/University Medical Center | Camden | New Jersey | 08103 | United States |
| Our Lady of Lourdes Medical Center | Camden | New Jersey | 08103 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| Kaleida Health | Buffalo | New York | 14209 | United States |
| Mount Sinai School Medical Center | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | United States |
| Wake Medical Center | Raleigh | North Carolina | 27610 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Ohio Health Research and Innovation Institute | Columbus | Ohio | 43214 | United States |
| Firelands Regional Medical Center | Sandusky | Ohio | 44870 | United States |
| Mercy St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Lankenau Institute for Medical Research | Bryn Mawr | Pennsylvania | 19010 | United States |
| Pinnacle Health at Harrisburg Hospital | Harrisburg | Pennsylvania | 17105 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Sisters of Charity Providence Hospital | Columbia | South Carolina | 29204 | United States |
| Jackson-Madison County General Hospital | Jackson | Tennessee | 38301 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Heart Hospital of Austin | Austin | Texas | 78756 | United States |
| Baylor Heart & Vascular Hospital | Dallas | Texas | 75226 | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Methodist Texsan Hospital | San Antonio | Texas | 78201 | United States |
| Trinity Mother Frances Health System | Tyler | Texas | 75701 | United States |
| Lynchburg General Hospital | Lynchburg | Virginia | 24501 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Deaconess Medical Center | Spokane | Washington | 99204 | United States |
| Providence Health & Services - Washington | Spokane | Washington | 99204 | United States |
| Aspirus Heart and Vascular Institute - Research and Education | Wausau | Wisconsin | 54401 | United States |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| St. Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| Royal Perth Hospital | Perth | 6000 | Australia |
| The Prince Charles Hospital | Queensland | 4032 | Australia |
| Allgemeines Krankenhauas AKH | Vienna | A-1090 | Austria |
| Academisch Ziekenhuis Middelheim | Antwerp | B-2020 | Belgium |
| Ziekenhuis Oost Limburg | Genk | 3600 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | B-9000 | Belgium |
| UZ Gasthuisberg | Leuven | B-3000 | Belgium |
| Skejby Sygehus | Aarhus | D-8200 | Denmark |
| Rigshospitalet Copenhagen | Copenhagen | 2100 | Denmark |
| Oulu University Hospital | Oulu | 90029 | Finland |
| Tampere University Hospital | Tampere | 33521 | Finland |
| Turku University Hospital | Turku | 20521 | Finland |
| CHU de Besancon | Besançon | 25030 | France |
| Clinique St. Augustin | Bordeaux | 33000 | France |
| Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier | Massy | 91300 | France |
| Clinique du Millenaire | Montpellier | 34960 | France |
| Centre Hopital Universitaire Rangueil | Toulouse | 31059 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Kerckhoff Klinik | Bad Nauheim | 61231 | Germany |
| Herz-und Diabeteszentrum Nordrhein-Westfalen | Bad Oeynhausen | 32545 | Germany |
| Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH | Bad Segeberg | 23795 | Germany |
| Universitatsklinik Charite Berlin | Berlin | 10117 | Germany |
| Universitat Heidelberg | Heidelberg | 69120 | Germany |
| Herzzentrum Universitat Leipzig | Leipzig | 04289 | Germany |
| Kokura Memorial Hospital | Kitakyushu-shi | Fukuoka | Japan |
| Japan Community Health Care Organization Hokkaido Hospital | Sapporo | Hokkaido | Japan |
| Shonan Kamakura General Hospital | Kamakura-shi | Kanagawa | Japan |
| Saiseikai Yokohama-City Eastern Hospital | Yokohama | Kanagawa | Japan |
| Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases | Fuchu-shi | Tokyo | Japan |
| Teikyo University Hospital | Itabashi-ku | Tokyo | Japan |
| Toho University Ohashi Medical Center | Meguro-ku | Tokyo | Japan |
| The Cardiovascular Institute Hospital | Minato-ku | Tokyo | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo | Japan |
| Sakurabashi Watanabe Hospital | Osaka | 530-0001 | Japan |
| P. Stradins University Hospital | Riga | Latvia |
| Sarawak General Hospital | Kota Samarahan | Sarawak | 94300 | Malaysia |
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands |
| Amphia Ziekenhuis | Breda | 4818CK | Netherlands |
| Catherina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| St Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Middlemore Hospital | Otahuhu | Auckland | 1640 | New Zealand |
| Ascot Angiography | Auckland | 1051 | New Zealand |
| Wellington Hospital | Wellington | 6021 | New Zealand |
| Szpital Uniwersytecki | Bydgoszcz | 85-094 | Poland |
| SPZOZ Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| National Institute of Cardiology | Warsaw | 04-628 | Poland |
| Military Hospital | Wroclaw | 50-891 | Poland |
| Hospital De Santa Cruz | Carnaxide | 2799-532 | Portugal |
| National Heart Centre Singapore | Singapore | 168752 | Singapore |
| Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital | London | England | SE1 7EH | United Kingdom |
| James Cook University Hospital | Middlesbrough | England | TS4 3BW | United Kingdom |
| John Radcliffe Infirmary Oxford II | Oxford | England | OX3 9DU | United Kingdom |
| Royal Victoria Hospital | Belfast | Ireland | BT12 6BA | United Kingdom |
| Golden Jubilee National Hospital | Clydebank | G81 4HX | United Kingdom |
| Southampton University Hospital | Southampton | SO16 6YD | United Kingdom |
| Derived |
| Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PROMUS | Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) |
| BG001 | PROMUS Element | Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device) |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group. | Number | participant |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
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| Cardiac History | The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group. | Number | Participant |
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| Cardiac History-Ejection Fraction | Mean | Standard Deviation | Percent Ejection Fraction |
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| Cardiac Risk Factor | The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group. | Number | Participant |
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| Comorbidities | The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group. | Number | Participants |
| |||||||||||||||||
| Lesion Characteristic: Target Lesion Vessel | Reported per lesion. The same participant may have been treated for >1 lesion and therefore may be included in more than one category. Thus, the total number of lesions for this baseline measure does not equal the total number of participants in the group. | Number | Lesion |
| |||||||||||||||||
| Lesion Characteristic: Lesion Location | Reported per lesion. The same participant may have been treated for >1 lesion and therefore may be included in more than one category. Thus, the total number of lesions for this baseline measure does not equal the total number of participants in the group. | Number | Lesions |
| |||||||||||||||||
| Lesion Characteristics | Mean | Standard Deviation | Millimeters |
| |||||||||||||||||
| Lesion Characteristic-Percent Diameter Stenosis | Mean | Standard Deviation | Percent Diameter Stenosis |
| |||||||||||||||||
| Lesion Characteristics | Reported per lesion. The same participant may have been treated for >1 lesion and therefore may be included in more than one category. Thus, the total number of lesions for this baseline measure does not equal the total number of participants in the group. | Number | Lesions |
| |||||||||||||||||
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class | Type A: minimally complex, readily accessible, non-angulated, smooth contour, little to no calcification, less than totally occlusive, not ostial in location, no major side branch involvement, absence of thrombus. Type B: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial location with presence of thrombus. Type C: severely complex, diffuse, excessive tortuosity and angulation, total occlusions > 3 months old, degenerated vein grafts,friable lesions | Number | Lesions |
| |||||||||||||||||
| Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow | TIMI 0 - No perfusion TIMI 1 - Penetration with minimal perfusion TIMI 2 - Partial perfusion TIMI 3 - Complete perfusion A participant may be treated for >1 lesion, therefore the number of lesions for this baseline measure does not equal the total number of participants in the group. | Number | Lesion |
|
| 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 | Target Lesion Failure (TLF) | Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set. | Posted | Number | percentage of participants | 12-month post index procedure |
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| Secondary | Target Lesion Failure (TLF) | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | Percentage of participants | 30 days |
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| Secondary | Target Lesion Failure (TLF) | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Target Lesion Failure (TLF) | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | Target Vessel Failure (TVF) | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 days |
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| Secondary | Target Vessel Failure (TVF) | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Target Vessel Failure (TVF) | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | Myocardial Infarction (MI) Related to the Target Vessel | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 days |
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| Secondary | Myocardial Infarction (MI) Related to the Target Vessel | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Myocardial Infarction (MI) Related to the Target Vessel | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | All Cause Mortality | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of patients | 30 days |
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| Secondary | All Cause Mortality | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
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| Secondary | All Cause Mortality | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 days |
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| Secondary | Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | Non-cardiac Death | Defined as a death not due to cardiac causes (see definition of cardiac death above) | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 Days |
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| Secondary | Non-cardiac Death | Defined as a death not due to cardiac causes (see definition of cardiac death above) | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 Months |
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| Secondary | Non-cardiac Death | Defined as a death not due to cardiac causes (see definition of cardiac death above) | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | Cardiac Death or Myocardial Infarction (MI) | Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 days |
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| Secondary | Cardiac Death or Myocardial Infarction (MI) | Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Cardiac Death or Myocardial Infarction (MI) | Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | All Death or Myocardial Infarction (MI) | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 days |
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| Secondary | All Death or Myocardial Infarction (MI) | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
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| Secondary | All Death or Myocardial Infarction (MI) | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | Target Lesion Revascularization (TLR) | Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 days |
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| Secondary | Target Lesion Revascularization (TLR) | TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Target Lesion Revascularization (TLR) | TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | Target Vessel Revascularization (TVR) | Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 days |
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| Secondary | Target Vessel Revascularization (TVR) | TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Target Vessel Revascularization (TVR) | TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
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| Secondary | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 24 hours |
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| Secondary | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | >24 hr-30 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | >30 days-1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | See above for definitions of MI and TVR | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | See above for definitions of MI and TVR. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | See above for definitions of MI and TVR. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Procedural Success | Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death | Analysis was intention to treat (all patients in study). | Posted | Number | percentage of participants | In hospital |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Technical Success | Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent | Analysis was intention to treat (all patients in the study). | Posted | Number | percentage of stents | Acute-At time of index procedure | Stents | Stents |
|
|
Site reported other adverse events were collected through 365 days.
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 | PROMUS | Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) | 237 | 762 | 190 | 762 | ||
| EG001 | PROMUS Element | Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device) | 238 | 768 | 197 | 768 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coronary artery perforation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac valve disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiomyopathy acute | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dressler's syndrome | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ischemic cardiomyopathy | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sinus bradychardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ulcer | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Intermittant claudication | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arterial disorder | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arterial stenosis limb | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstruction airways disease | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneomonia haemophilus | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diaphragmatic hernia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperventillation | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Inguinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain upper | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Mesenteric artery stenosis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cholitis ischaemic | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Acute leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Benign bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Benign renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pseudarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Spinal ligament ossification | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bladder tamponade | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diabetes ketoacidosis | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Cardiac enzymes increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Cardiac stress test abnormal | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (12.0) | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
|
The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth Starzyk, PhD | Boston Scientific Corporation | 508-683-6577 | ruth.starzyk@bsci.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| C446540 | thienopyridine |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| >=65 years |
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| Male |
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| Hispanic or Latino |
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| Asian |
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| Black of African heritage |
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| Native Hawaiian or other Pacific Islander |
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| American Indian or Alaska Native |
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| Other |
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| Maori |
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| Not Disclosed |
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| Japan |
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| Europe |
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| Pacifica |
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| Previous Coronary Artery Bypass Graft (CABG) |
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| Previous Myocardial Infarction (MI) |
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| Congestive Heart Failure |
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| Stable Angina |
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| Unstable Angina |
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| Silent Ischemia |
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| Medically Treated Diabetes |
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| Hyperlipidemia Requiring Medication |
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| Hypertension Requiring Medication |
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| Family History of Coronary Artery Disease |
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| History of Transient Ischemic Attack |
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| History of Cerebrovascular Accident |
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| History of Renal Disease |
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| History of Gastrointestinal Bleeding |
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| Left Circumflex Artery |
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| Right Coronary Artery |
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| Proximal |
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| Mid |
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| Distal |
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| Minimum Lumen Diameter |
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| Lesion Length |
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| > 45 Degree Bend |
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| > 90 Degree Bend |
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| Tortuosity, any |
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| Calcification, any |
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| Total Occlusion |
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| Bifurcation |
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| Type B1 |
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| Type B2 |
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| Type C |
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