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Comparison of Coronary Xience V and the Cypher Select+ Stents in Diabetic Patients (DIABEDES IV)

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00552994
First received: October 31, 2007
Last updated: July 9, 2010
Last verified: August 2009
History of Changes

October 31, 2007
July 9, 2010
August 2007
July 2009   (final data collection date for primary outcome measure)
In stent neointimal hyperplasia [ Time Frame: Within 10 months ] [ Designated as safety issue: No ]
In stent neointimal hyperplasia [ Time Frame: within 10 months ]
Complete list of historical versions of study NCT00552994 on ClinicalTrials.gov Archive Site
Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss [ Time Frame: Within 10 months ] [ Designated as safety issue: No ]
Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss [ Time Frame: Within 10 months ]
Not Provided
Not Provided
 
Comparison of Coronary Xience V and the Cypher Select+ Stents in Diabetic Patients
A Danish Prospective Randomized Multicenter Comparison of the Xience V and the Cypher Select+ Stents in Unselective Patients With Diabetes Mellitus. An Intravascular Ultrasound Study.

In stent neointimal hyperplasia may be less in the Cypher select plus stent compared to the Xience V stent in diabetic patients.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
  • Device: Cypher Select plus
    Drug eluting stent
  • Device: Xience V stent
    Drug eluting stent
  • Active Comparator: 1
    Cypher Select plus stent
    Intervention: Device: Cypher Select plus
  • Active Comparator: 2
    Xience V stent
    Intervention: Device: Xience V stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All diabetic patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.

Exclusion Criteria:

  • The patient will not participate
  • The patient participates in other randomised 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
 
NCT00552994
IVUS-20070043
Yes
Lisette Okkels Jensen, Odense University Hospital, Denmark
Odense University Hospital
Not Provided
Principal Investigator: Per Thayssen, MD DMSci Odense University Hospital
Odense University Hospital
August 2009

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