XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study (XV CHINA SAS)

Abbott

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Vascular Disease; Coronary Restenosis; Angioplasty; Coronary Artery Stenosis; Coronary Disease; Chronic Coronary Occlusion; Stent Thrombosis

Treatments: Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Study type: Observational

Funder types: Industry

Identifiers

NCT01249027

10-388

Details and patient eligibility

About

This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to:

• Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use
• Evaluate patient compliance to dual antiplatelet therapy (DAPT)

Enrollment: 2,605 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee-approved informed consent form (ICF).
• Only XIENCE V stent(s) is/are implanted into the coronary vasculature during the index procedure.

Exclusion criteria

• The inability to obtain a signed ICF

Trial design

2,605 participants in 1 patient group

Observational

Description:

Single arm prospective, observational, single-arm, open-label, multicenter, postapproval registry study using XIENCE V® Everolimus Eluting Coronary Stent System (EECSS).

Treatment:

Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)