XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)

NCT ID: NCT01120379

Last Updated: 2015-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5034 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-12-31

Brief Summary

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

Among patients enrolled in the XIENCE V USA who have completed Study Phase I, some will be eligible to participate in the XIENCE V USA Long Term Follow-up (LTF) Cohort. This LTF cohort is a prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS continued safety and effectiveness in real world settings from 1 year after the index procedure up to 5 years. The XIENCE V USA LTF cohort will consist of the following from the initial 5,000 patients:

• The first 1,500 on-label patients who are treated in accordance with the XIENCE V EECSS Instruction for Use (IFU), and consecutively enrolled in the XIENCE V USA study
• The remaining patients who do not participate in the HCRI-DAPT cohort
• Data monitoring committee up to two years

Conditions

Chronic Coronary Occlusion; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

XV-LTF cohort

XIENCE V® EECSS

Intervention Type: DEVICE

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

Interventions

XIENCE V® EECSS

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

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

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Hermiller, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center of Indianapolis

Mitch Krucoff, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Abbott Vascular

Santa Clara, California, United States

Countries

United States

Related Links

http://www.clinicaltrials.gov/ct2/show/NCT00676520?term=xience+v+usa&rank=3

NCT00676520

http://www.clinicaltrials.gov/ct2/show/NCT01106534?term=xience+v+usa&rank=1

NCT01106534

Other Identifiers

06-374B

Identifier Type: -

Identifier Source: org_study_id