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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014