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

Overview

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.

Full Title of Study: “XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2010

Detailed Description

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.

Interventions

  • Device: XIENCE V® Everolimus Eluting Coronary Stent
    • Drug eluting stent implantation stent in the treatment of coronary artery disease

Arms, Groups and Cohorts

  • 1
    • The group will be monitored to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Composite rate of cardiac death and any MI (Q-wave and non Q-wave)
    • Time Frame: at 30, 180 days and at 2 and 3 years
  • Composite rate of all death and any MI (Q-wave and non Q-wave)
    • Time Frame: 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)
    • Time Frame: at 30, 180 days and at 2 and 3 years
  • Death (cardiac death, vascular death, and non-cardiovascular death)
    • Time Frame: at 30, 180 days and at 2 and 3 years
  • Any MI (Q-wave and non Q-wave)
    • Time Frame: at 30, 180 days and at 2 and 3 years
  • Major bleeding complications
    • Time Frame: at 14, 30, 180 days and at 1, 2 and 3 years
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
    • Time Frame: 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)
    • Time Frame: at 30, 180 days and at 1, 2 and 3 years
  • Clinical device and procedural success
    • Time Frame: Acute
  • Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire
    • Time Frame: at baseline, 180 days, and 1 year
  • Stent thrombosis
    • Time Frame: 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)
    • Time Frame: 30, 180 days and 1, 2 and 3 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ashok Seth, MD, Principal Investigator, Max Devki Devi Heart & Vascular Institute
    • Tejas Patel, MD, Principal Investigator, Krishna Heart Institute

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