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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

September 12, 2008
April 18, 2013
August 2008
October 2010   (final data collection date for primary outcome measure)
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 ]
Composite endpoint of Cardiac death and Myocardial Infarction (not clearly attributable to a non-target vessel) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00752128 on ClinicalTrials.gov Archive Site
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 ]
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: Yes ]
Not Provided
Not Provided
 
RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population
RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Coronary Artery Disease
  • Cardiovascular Diseases
Device: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System
Stent implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2349
December 2012
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00752128
IP091
Yes
Medtronic Vascular
Medtronic Vascular
Medtronic Bakken Research Center
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
Medtronic Vascular
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP