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

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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

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

Trial contacts and locations

47

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Data sourced from clinicaltrials.gov

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