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The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.
The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Diabetic study after 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAXUS® Liberté™ | Active Comparator |
| |
| XIENCE V® EECSS | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAXUS® Liberté™ | Device | Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent Late Loss (LL) | In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up | 270 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Device Success (Per-lesion) | Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy. |
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Inclusion Criteria:
Exclusion Criteria:
Target lesion meets any of the following criteria:
The target vessel contains visible thrombus
Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)
Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
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| Name | Affiliation | Role |
|---|---|---|
| Eberhard Grube, MD | International Heart Center Rhein-Ruhr, Essen, Germany | Principal Investigator |
| Upendra Kaul, MD | Fortis Hospital, New Delhi, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salzburger Landeskliniken | Salzburg | Austria | ||||
| C.H.U. - Hopital Michallon |
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| Label | URL |
|---|---|
| SPIRIT V registry arm | View source |
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Subjects were randomized via telephone randomization and stratified by insulin treatment status, number of lesions treated-single vs. multiple. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.
324 subjects were recruited at 32 sites. Eligible subjects invited to participate, in-hospital or in-clinic and required to provide signed informed consent prior to enrollment. Final eligibility based on angiographic inclusion criteria prior to the intended procedure. Dates of recruitment: April 28, 2007 to October 6, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAXUS® Liberté™ | Patients receiving the TAXUS® Liberté™ stent during PCI |
| FG001 | XIENCE V® EECSS | Patients receiving the XIENCE V® EECSS stent during percutaneous coronary intervention (PCI) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| XIENCE V® EECSS | Device | Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes |
|
| immediately post-procedure |
| Clinical Procedure Success (Per-patient) | Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success. | immediately post-procedure |
| In-segment Late Loss | In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up | 270 days |
| Proximal Late Loss | Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up | 270 day |
| Distal Late Loss | Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up | 270 days |
| In-stent Angiographic Binary Restenosis Rate | Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA. | 270 days |
| In-segment Angiographic Binary Restenosis Rate | Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA. | 270 days |
| In-stent Percent Diameter Stenosis (% DS) | This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | 270 days |
| In-segment Percent Diameter Stenosis (% DS) | This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | 270 days |
| Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) | The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement. | 0 to 37 days |
| Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) | The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement. | 254 days |
| Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) | The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement. | 365 days |
| Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs. | 37 days |
| Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs. | 254 days |
| Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs. | 393 days |
| Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) | Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs. | 37 days |
| Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) | Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs. | 254 days |
| Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) | Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs. | 393 days |
| Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | 37 days |
| Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | 254 days |
| Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | 393 days |
| Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR | 37 days |
| Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR | 254 days |
| Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR | 393 days |
| Grenoble |
| France |
| CHU Lille - Hôpital Cardiologique | Lille | France |
| Herzzentrum | Bernau | Germany |
| Universitätsklinikum | Heidelberg | Germany |
| Lukas Krankenhaus Neuss | Neuss | Germany |
| Herzzentrum Siegburg GmbH | Siegburg | Germany |
| Sheba Medical Center | Ramat Gan | Israel |
| Azienda Ospedaliera Riuniti | Bergamo | Italy |
| Ospedale Civile | Mirano | Italy |
| Azienda Ospedaliera di Padova | Padova | Italy |
| IRCCS Policlinico San Matteo | Pavia | Italy |
| Azienda Ospedaliera S. Gdi Dio Salerno | Salerno | Italy |
| Institute Jantung Negara | Kuala Lumpur | Malaysia |
| Medisch Centrum Alkmaar | Alkmaar | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | Netherlands |
| Medical University of Bydgoszcz | Bydgoszcz | Poland |
| General De Alicante | Alicante | Spain |
| Hospital Belvigte de Barcelona | Barcelona | Spain |
| Hospital Santa Creu I Sant Pau | Barcelona | Spain |
| Clinico San Carlos | Madrid | Spain |
| Hospital Puerta de Hierro | Madrid | Spain |
| La Paz | Madrid | Spain |
| Hospital Virgen de la Arrixaca | Murcia | Spain |
| Hospital General de Valencia | Valencia | Spain |
| King Chulalongkorn Memorial Hospital | Bangkok | Thailand |
| Wessex Cardiac Unit | Southampton | Southampton | SO16 6YD | United Kingdom |
| King's College Hospital | London | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAXUS® Liberté™ | Patients receiving the TAXUS® Liberté™ stent during PCI |
| BG001 | XIENCE V® EECSS | Patients receiving the XIENCE V® EECSS stent during PCI |
| 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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| Region of Enrollment | Number | participants |
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| 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 | In-stent Late Loss (LL) | In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up | Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. | Posted | Mean | Standard Deviation | millimeters | 270 days | lesions | Participants |
|
|
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| Secondary | Clinical Device Success (Per-lesion) | Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy. | Analysis based on intention to treat (ITT) population. | Posted | Number | 95% Confidence Interval | Percentage of lesions | immediately post-procedure | Lesions | Participants |
|
| |||||||||||||||||||||||||||||
| Secondary | Clinical Procedure Success (Per-patient) | Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success. | The sample size for clinical procedure success is based on the number of evaluable patients, for whom data is available to define clinical procedure success. | Posted | Number | 95% Confidence Interval | Percentage of participants | immediately post-procedure |
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| Secondary | In-segment Late Loss | In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up | Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. | Posted | Mean | Standard Deviation | millimeters | 270 days | lesions | Participants |
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| Secondary | Proximal Late Loss | Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up | Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. | Posted | Mean | Standard Deviation | millimeters | 270 day | lesions | Participants |
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| Secondary | Distal Late Loss | Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up | Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. | Posted | Mean | Standard Deviation | millimeters | 270 days | lesions | Participants |
|
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| Secondary | In-stent Angiographic Binary Restenosis Rate | Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA. | Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | 270 days | lesions | Participants |
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| Secondary | In-segment Angiographic Binary Restenosis Rate | Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA. | Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | 270 days | lesions | Participants |
|
| |||||||||||||||||||||||||||||
| Secondary | In-stent Percent Diameter Stenosis (% DS) | This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. | Posted | Mean | Standard Deviation | Percent diameter stenosis | 270 days | lesions | Participants |
|
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| Secondary | In-segment Percent Diameter Stenosis (% DS) | This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. | Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. | Posted | Mean | Standard Deviation | Percent diameter stenosis | 270 days | lesions | Participants |
|
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| Secondary | Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) | The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 0 to 37 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) | The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 254 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) | The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 365 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 37 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 254 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 393 days |
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| Secondary | Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) | Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 37 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) | Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 254 days |
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| Secondary | Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) | Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 393 days |
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| Secondary | Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 37 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 254 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 393 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 37 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 254 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR | Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. | Posted | Number | 95% Confidence Interval | Percentage of participants | 393 days |
|
|
1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
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 | TAXUS® Liberté™ | Patients receiving the TAXUS® Liberté™ stent during PCI | 41 | 105 | 13 | 105 | ||
| EG001 | XIENCE V® EECSS | Patients receiving the XIENCE V® EECSS stent during PCI | 100 | 215 | 26 | 215 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial septal defect | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery restenosis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| In-stent coronary artery restenosis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial infarction, acute | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Catheter site haematoma | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Noncardiac chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Instent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac stress test abnormal | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Troponin T | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetic foot | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Meniscus lesion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Hodgkins disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Lip andor oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Peritoneal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vocal cord disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary angioplasty | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary revascularisation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes mellitus management | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery dissection | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Smith Jr, Ph.D., Sr Clinical Research Scientist | Abbott Vascular | 408-845-8265 | robert.smithjr@av.abbott.com |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| D023903 | Coronary Restenosis |
| D014652 | Vascular Diseases |
| D017202 | Myocardial Ischemia |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided
| >=65 years |
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| Male |
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| Thailand |
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| Spain |
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| Poland |
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| Malaysia |
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| Austria |
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| Israel |
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| Netherlands |
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| Germany |
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| United Kingdom |
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| Italy |
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Patients receiving the XIENCE V® EECSS stent during PCI |
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