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

Completed

• Conditions: Coronary Artery Disease; Cardiovascular Diseases

• Registration Number: NCT00752128
• Lead Sponsor: Medtronic Vascular

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-15
• Primary Completion: 2010-10
• Results First Submitted: 2011-10-31
• Results First Submitted QC: 2011-10-31
• Results First Posted: 2011-12-06
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2349

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)	12 Months

Secondary Outcome Measures

Name	Time	Method
Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition	12 Months

Trial Locations

Locations (1)

Heart Center Bad Krozingen; 🇩🇪 Bad Krozingen, Germany