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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-08-31

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.

Conditions

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Coronary Disease Coronary Artery Disease Coronary Restenosis

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

XIENCE V® Everolimus Eluting Coronary Stent

Intervention Type DEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease

Interventions

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XIENCE V® Everolimus Eluting Coronary Stent

Drug eluting stent implantation stent in the treatment of coronary artery disease

Intervention Type DEVICE

Other Intervention Names

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XIENCE V® Everolimus Eluting Coronary Stent System

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashok Seth, MD

Role: PRINCIPAL_INVESTIGATOR

Max Devki Devi Heart & Vascular Institute

Tejas Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Krishna Heart Institute

Explore related publications, articles, or registry entries linked to this study.

Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

Reference Type DERIVED

PMID: 25940520 (View on PubMed)

Other Identifiers

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REFCTRI000213, 21-10-2008

Identifier Type: REGISTRY

Identifier Source: secondary_id

07-378

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

XIENCE V® Everolimus Eluting Coronary Stent

Interventions

XIENCE V® Everolimus Eluting Coronary Stent

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Abbott Medical Devices

Responsible Party

Principal Investigators

Ashok Seth, MD

Tejas Patel, MD

Locations

CARE Hospital

Krishna Heart Institute,

Krishna Heart Institute

Jehangir Hospital

Dayanand Medical College & Hospital

Christian Medical Center (CMC)

SAL Hospital And Medical Institute

Escorts Heart & Superspeciality Institute Ltd.

Madras Medical Mission

Apollo Hospital

Heart & General Hospital

Lisie Heart Institute,Lisie Hosp.

Holy Family Hospital

Escorts Heart Institute & Research Centre

Fortis Hospital

Max Devki Devi Heart & Vascular Institute

Escorts Heart Institute & Research Centre

Poona Hospital And Research Centre

Countries

References

Other Identifiers

REFCTRI000213, 21-10-2008

07-378