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

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ClinicalTrials.gov Identifier: NCT00752128
Recruitment Status : Completed
First Posted : September 15, 2008
Results First Posted : December 6, 2011
Last Update Posted : April 25, 2013
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
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.

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

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
Actual Enrollment : 2349 participants
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
Study Start Date : August 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2012

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


Primary Outcome Measures :
  1. Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel) [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 15, 2008    Key Record Dates
Results First Posted: December 6, 2011
Last Update Posted: April 25, 2013
Last Verified: April 2013

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
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs