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

Abbott

Status

Completed

Conditions

Coronary Artery Disease

Myocardial Ischemia

Vascular Disease

Coronary Restenosis

Coronary Artery Stenosis

Coronary Disease

Chronic Coronary Occlusion

Treatments

Device: XIENCE V® EECSS

Study type

Observational

Funder types

Industry

Identifiers

NCT01120379

06-374B

Details and patient eligibility

About

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.

Full 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

Enrollment

5,034 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria