Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients (SORT-OUTIII)

This study has been completed.
Sponsor:
Collaborators:
Aalborg Universityhospital
Odense University Hospital
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00660478
First received: April 9, 2008
Last updated: August 28, 2013
Last verified: September 2008

April 9, 2008
August 28, 2013
January 2006
December 2007   (final data collection date for primary outcome measure)
In a randomized study to compare the Endeavor and the Cypher Select coronary stents by assessing MACE (cardiac death, myocardial infarction, stent thrombosis and target vessel revascularization) after 9 months. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00660478 on ClinicalTrials.gov Archive Site
To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients
Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients

Randomized clinical comparison of the serolimus eluting Cypher stent and the zotarolimus eluting Endeavor stent.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Heart Disease
  • Device: Endeavor
    Comparison of two different drug eluting coronary stents
    Other Name: 1. Endeavor
  • Device: Cypher Select
    Comparison of two different drug eluting coronary stents
    Other Name: 1. Cypher
  • Active Comparator: 1
    Zotarolimus eluting stent
    Intervention: Device: Endeavor
  • Active Comparator: 2
    Sirolimus stent
    Intervention: Device: Cypher Select

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2342
October 2009
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centers in Denmark can be included in the study.

Exclusion Criteria:

  • The patient will not participate
  • The patient participates in other randomized stent studies
  • Expected survival < 1 year
  • Allergy to Aspirin, Clopidogrel or Ticlopidine
  • Allergy to Sirolimus or ABT-578
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00660478
20050194
Yes
Evald Hoej Christiansen, Aarhus University Hospital Skejby
Evald Hoej Christiansen
  • Aalborg Universityhospital
  • Odense University Hospital
  • University Hospital, Gentofte, Copenhagen
  • Rigshospitalet, Denmark
Study Chair: Jens F Lassen, MD, PhD Skejby Hospital
Principal Investigator: Klaus Rasmussen, MD, DMSc Aalborg Universityhospital
Aarhus University Hospital Skejby
September 2008

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