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

This study has been completed.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00752128
First received: September 12, 2008
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Cardiovascular Diseases
 Device: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 2349
Study Start Date: August 2008
Study Completion Date: December 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752128

Locations
Germany
Heart Center Bad Krozingen
Bad Krozingen, Germany
Sponsors and Collaborators
Medtronic Vascular
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
  More Information

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00752128     History of Changes
Other Study ID Numbers: IP091
Study First Received: September 12, 2008
Results First Received: October 31, 2011
Last Updated: April 18, 2013
Health Authority: Argentina: Human Research Bioethics Committee
Belgium: Institutional Review Board
Estonia: Institutional Review Board
Finland: Ethics Committee
Germany: Ethics Commission
Greece: Ethics Committee
India: Institutional Review Board
Netherlands: Independent Ethics Committee
Portugal: Ethics Committee
South Africa: Human Research Ethics Committee
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee

Keywords provided by Medtronic Vascular:
Drug Eluting Stent
Interventional Cardiology
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
 Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013