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

Coronary Artery Disease Clinical Trial

— R-Int  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752128
• Other study ID #: IP091
• Status: Completed
• Phase: N/A
• First received: September 12, 2008
• Last updated: April 18, 2013
• Start date: August 2008
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeBelgium: Institutional Review BoardEstonia: Institutional Review BoardFinland: Ethics CommitteeGermany: Ethics CommissionGreece: Ethics CommitteeIndia: Institutional Review BoardNetherlands: Independent Ethics CommitteePortugal: Ethics CommitteeSouth Africa: Human Research Ethics CommitteeSwitzerland: EthikkommissionUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2349
• Est. completion date: December 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Endeavor Resolute Zotarolimus-Eluting Coronary Stent System
Stent implantation

Locations

Country	Name	City	State
Germany	Heart Center Bad Krozingen	Bad Krozingen

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Vascular	Medtronic Bakken Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)		12 Months	No
Secondary	Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition		12 Months	No