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XIENCE™ V Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE™ V USA)
This study is currently recruiting participants.
Verified by Abbott Vascular, December 2008
Sponsored by: Abbott Vascular
Information provided by: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00676520
  Purpose

This prospective, open-label, multi-center, observational, single-arm registry is designed to evaluate XIENCE V EECSS continued safety and efficacy during commercial use in real world settings.


Condition Intervention Phase
Coronary Artery Disease
Device: XIENCE™ V Everolimus Eluting Coronary Stent
Phase IV

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: Everolimus
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: XIENCE™ V Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Academic Research Consortium (ARC) defined stent thrombosis [ Time Frame: Annually through to 5 years ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death and any myocardial infarction (MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stent thrombosis [ Time Frame: at 24 hours and 30 days ] [ Designated as safety issue: Yes ]
  • Composite rate of all death, any MI and any repeat revascularization (percutaneous coronary intervention [PCI] and coronary artery bypass graft [CABG]) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Composite rate of cardiac death, any MI attributed to the target vessel, and target lesion revascularization (TLR) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Death (cardiac death, vascular death, non-cardiovascular death) [ Time Frame: at 30, 180, days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • MI (both Q-wave and non Q-wave) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Revascularization: TLR, TVR and non-TVR.(both PCI and CABG) [ Time Frame: at 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: at 14, 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: at 14, 30, 180 days and at 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Clinical device and procedural success [ Time Frame: Acute ] [ Designated as safety issue: No ]
  • Patient health status (symptoms, physical function, and quality of life) as assessed by the Seattle Angina Questionnaire [ Time Frame: at baseline, 180 days, and 1 year ] [ Designated as safety issue: No ]
  • Composite rate of cardiac death and any MI [ Time Frame: 30, 180 days and 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]
  • Composite rate of all death and any MI [ Time Frame: 30, 180 days and 1, 2, 3, 4, 5 years. ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 5000
Study Start Date: July 2008
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Single arm registry
Device: XIENCE™ V Everolimus Eluting Coronary Stent
Single-arm registry designed to evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings.

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 the United States of America (USA) 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.2,3 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 USA Post-Approval Study (XIENCE V USA) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who agree to participate and who recieve a XIENCE V EECSS to evaluate continued safety and effectiveness during commercial use in real world settings from a wide variety of physician practices.

Criteria

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 to be determined by physicians.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676520

Contacts
Contact: Vivian Mao 408-845-1489 vivian.mao@av.abbott.com

  Show 108 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: James Hermiller, MD Heart Center of Indianapolis
Principal Investigator: Mitch Krucoff, MD Duke University
  More Information

Responsible Party: Abbott Cardiovascular Systems, Inc., A Subsidiary of Abbott Vascular, Inc. ( Vivian Mao )
Study ID Numbers: 06-374
Study First Received: October 16, 2007
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00676520  
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
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 placed in the following topic categories:
Everolimus
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia
Arteriosclerosis
Coronary Restenosis
Coronary Stenosis
Thrombosis
Coronary Disease
Coronary Occlusion
Coronary Artery Disease

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Cardiovascular Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009