RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population (R-Int)

Medtronic

Status: Completed

Conditions: Coronary Artery Disease; Cardiovascular Diseases

Treatments: Device: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT00752128

IP091

Details and patient eligibility

About

The primary objective of the RESOLUTE international registry is to document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a 'real-world' patient population requiring stent implantation.

Full description

As part of the broader clinical program of the Resolute stent, the RESOLUTE International registry will expand the experience and understanding of the device performance in a 'real-world' setting. The registry intends to enroll patients from a large number of centers under commercial usage conditions, with the aim to reflect 'real-world' usage as much as possible.

Enrollment: 2,349 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum legal age (18)
• Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines
• Patient has consented to participate and authorized in writing the collection and release of medical information
• Elective use of the Endeavor Resolute stent

Exclusion criteria

• Pregnancy
• High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
• Currently participating in another trial preventing routine hospital treatment
• Previous enrollment in the RESOLUTE International registry