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

April 18, 2013 updated by: Medtronic Vascular
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2349

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Krozingen, Germany
        • Heart Center Bad Krozingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Endeavor Resolute stent in one or more target lesions are candidates to be enrolled

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Vascular

Collaborators

Medtronic Bakken Research Center

Investigators

  • Principal Investigator: Franz-Josef Neumann, MD, Heart Center Bad Krozingen, Germany
  • Principal Investigator: Petr Widimský, MD, University Hospital Kralovské Vinohrady, Czech Republic
  • Principal Investigator: Jorge A. Belardi, MD, Instituto Cardiovascular de Buenos Aires, Argentina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (Estimate)

September 15, 2008

Study Record Updates

Last Update Posted (Estimate)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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