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

August 13, 2012 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India, 380054
        • Sal Hospital and Medical Institute
      • Amritsar, India
        • Escorts Heart & Superspeciality Institute Ltd.
      • Chennai, India, 600 037
        • Madras Medical Mission
      • Cochin, India
        • Lisie Heart Institute,Lisie Hosp.
      • Hyderabad, India, 500033
        • Apollo Hospital
      • Jaipur, India
        • Heart & General Hospital
      • Mumbai, India, 400050
        • Holy Family Hospital
      • New Delhi, India, 110025
        • Escorts Heart Institute & Research Centre
      • New Delhi, India, 110017
        • Max Devki Devi Heart & Vascular Institute
      • New Delhi, India, 110 070
        • Escorts Heart Institute & Research Centre
      • New Delhi, India, 110 070
        • Fortis Hospital
      • Pune, India, 411030
        • Poona hospital and research centre
      • Pune, India, 411001
        • Jehangir Hospital
    • Andhra Pradesh
      • Hyderabaad, Andhra Pradesh, India, 500034
        • Care hospital
      • Hyderabad, Andhra Pradesh, India, 5000003
        • Krishna Heart Institute,
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 006
        • Krishna Heart Institute
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College & Hospital
    • Tamilnadu
      • Vellore, Tamilnadu, India, 632004
        • Christian Medical Center (CMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The group will be all consecutively enrolled patients in India treated by a broad group of physicians at a variety of health care facilities, who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
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
Drug eluting stent implantation stent in the treatment of coronary artery disease
Other Names:
  • XIENCE V® Everolimus Eluting Coronary Stent System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
at 30, 180 days and at 1, 2 and 3 years
Clinical device and procedural success
Time Frame: Acute
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
at baseline, 180 days, and 1 year
Stent thrombosis
Time Frame: 24 hours (acute) and 30 days (sub-acute)
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
30, 180 days and 1, 2 and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Ashok Seth, MD, Max Devki Devi Heart & Vascular Institute
  • Principal Investigator: Tejas Patel, MD, Krishna Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-378
  • REFCTRI000213, 21-10-2008 (Registry Identifier: Clinical Trials Registry - India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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