XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study

Study Overview
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Brief Summary
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XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Detailed Description
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Long term surveillance studies using a drug eluting stent (DES) may help elucidate mechanisms responsible for death, myocardial infarction, and late stent thrombosis risks not observed during controlled pre-market trials. This study will evaluate XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) performance in the real world when used by a broad group of physicians at a variety of health care facilities. Consequently, this protocol will include all consecutively enrolled patients in India who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization. Adjunctive anti-platelet therapy is a critical factor in optimizing long term DES safety. Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE V® EECSS India Post-marketing Single-Arm Study (XIENCE V® India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study. 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 XIENCE V India 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 XIENCE V India study, from 5 years to after completion of the three year follow-up.

Official Title
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XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study

Conditions
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Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Intervention / Treatment
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* Device: XIENCE V® Everolimus Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient agrees to participate in this study by signing the EC approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form. Exclusion Criteria: The inability to obtain an informed consent is an exclusion criterion.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>The group will be monitored to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings. | Device: XIENCE V® Everolimus Eluting Coronary Stent<br>* Drug eluting stent implantation stent in the treatment of coronary artery disease<br>* Other names: XIENCE V® Everolimus Eluting Coronary Stent System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent thrombosis rates as defined by Academic Research Consortium (ARC) |  | Annually through to 3 years | 
| Composite endpoint of cardiac death and myocardial infarction (MI) |  | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite rate of cardiac death and any MI (Q-wave and non Q-wave) |  | at 30, 180 days and at 2 and 3 years | 
| Composite rate of all death and any MI (Q-wave and non Q-wave) |  | at 30, 180 days and at 2 and 3 years | 
| Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG) |  | at 30, 180 days and at 2 and 3 years | 
| Death (cardiac death, vascular death, and non-cardiovascular death) |  | at 30, 180 days and at 2 and 3 years | 
| Any MI (Q-wave and non Q-wave) |  | at 30, 180 days and at 2 and 3 years | 
| Major bleeding complications |  | at 14, 30, 180 days and at 1, 2 and 3 years | 
| Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy |  | at 14, 30, 180 days and at 1, 2 and 3 years | 
| Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) |  | at 30, 180 days and at 1, 2 and 3 years | 
| Clinical device and procedural success |  | Acute | 
| Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire |  | at baseline, 180 days, and 1 year | 
| Stent thrombosis |  | 24 hours (acute) and 30 days (sub-acute) | 
| Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG) |  | 30, 180 days and 1, 2 and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis