XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

Abbott

Status: Completed

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

Treatments: Device: XIENCE V / PROMUS stent

Study type: Observational

Funder types: Industry

Identifiers

NCT01086228

09-384

Details and patient eligibility

About

The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.

Full description

The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.

Enrollment: 2,010 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Exclusion criteria

• Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Trial design

2,010 participants in 1 patient group

XIENCE V / PROMUS stent

Description:

Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.

Treatment:

Device: XIENCE V / PROMUS stent