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XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)

NCT ID: NCT00676520

Last Updated: 2012-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8053 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-03-31

Brief Summary

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XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are

* To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and
* To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Detailed Description

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Study Phase I is from index procedure to 1 year. This prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS safety and effectiveness in real world settings up to 1 year after implantation. The primary endpoint is the stent thrombosis (definite and probable) rate up to 1 year as ARC. The co-primary endpoint is the composite rate of cardiac death and any MI at 1 year. Up to 8,000 patients are planned to be consecutively enrolled at up to 275 sites in the U.S. Clinical follow-up will occur at 14, 30, 180 days and 1 year.

All patients enrolled in the XIENCE V USA who have completed Study Phase I will be evaluated at 1 year to determine whether they are eligible to participate in one of the following cohorts in Study Phase II: XIENCE V USA Long Term Follow-up (LTF) Cohort, Harvard Clinical Research Institute (HCRI) DAPT Cohort, or Abbott Vascular (AV) DAPT Cohort.

Conditions

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Coronary Artery Disease

Keywords

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Angioplasty Coronary Restenosis Coronary Artery Disease Coronary Artery Restenosis Coronary Artery Stenosis Total Artery Occlusion Stents Stent Thrombosis Total Coronary Occlusion Vascular Disease Myocardial Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Single-arm study

XIENCE V® Everolimus Eluting Coronary Stent

Intervention Type DEVICE

Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Interventions

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XIENCE V® Everolimus Eluting Coronary Stent

Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.

Exclusion Criteria

* The inability to obtain an informed consent.

Age limit is determined by investigator.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Hermiller, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center of Indianapolis

Mitch Krucoff, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Abbott Vascular

Santa Clara, California, United States

Site Status

Countries

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United States

References

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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)

Sudhir K, Hermiller JB, Naidu SS, Henry TD, Mao VW, Zhao W, Ferguson JM, Wang J, Jonnavithula L, Simonton CA, Rutledge DR, Krucoff MW; XIENCE V USA Investigators. Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V(R) everolimus-eluting stents: one-year results from the XIENCE V USA study. Catheter Cardiovasc Interv. 2013 Oct 1;82(4):E385-94. doi: 10.1002/ccd.24749. Epub 2013 Mar 28.

Reference Type DERIVED
PMID: 23172848 (View on PubMed)

Hermiller JB, Rutledge DR, Gruberg L, Katopodis JN, Lombardi W, Mao VW, Zhao W, Sharma SK, Tamboli HP, Wang J, Jonnavithula L, Sudhir K, Krucoff MW. Sustained low clinical event rates in real-world patients receiving everolimus-eluting coronary stent system from a large, prospective, condition of approval study: 2-year clinical outcomes from the XIENCE V USA Study. J Interv Cardiol. 2012 Dec;25(6):565-75. doi: 10.1111/j.1540-8183.2012.00766.x. Epub 2012 Sep 23.

Reference Type DERIVED
PMID: 22998355 (View on PubMed)

Naidu SS, Krucoff MW, Rutledge DR, Mao VW, Zhao W, Zheng Q, Wilburn O, Sudhir K, Simonton C, Hermiller JB. Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8,061-patient XIENCE V United States study. JACC Cardiovasc Interv. 2012 Jun;5(6):626-35. doi: 10.1016/j.jcin.2012.02.014.

Reference Type DERIVED
PMID: 22721657 (View on PubMed)

Krucoff MW, Rutledge DR, Gruberg L, Jonnavithula L, Katopodis JN, Lombardi W, Mao VW, Sharma SK, Simonton CA, Tamboli HP, Wang J, Wilburn O, Zhao W, Sudhir K, Hermiller JB. A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study). JACC Cardiovasc Interv. 2011 Dec;4(12):1298-309. doi: 10.1016/j.jcin.2011.08.010.

Reference Type DERIVED
PMID: 22192371 (View on PubMed)

Other Identifiers

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06-374

Identifier Type: -

Identifier Source: org_study_id