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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:
ClinicalTrials.gov Identifier:
NCT00552994
First Posted: November 2, 2007
Last Update Posted: July 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Odense University Hospital
October 31, 2007
November 2, 2007
July 12, 2010
August 2007
July 2009   (Final data collection date for primary outcome measure)
In stent neointimal hyperplasia [ Time Frame: Within 10 months ]
Same as current
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 ]
Same as current
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 (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
Antonsen L, Maeng M, Thayssen P, Christiansen EH, Hansen KN, Kaltoft A, Hansen HS, Thuesen L, Lassen JF, Jensen LO. Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients: the randomized Diabetes and Drug-Eluting Stent (DiabeDES) IV Intravascular Ultrasound trial. Catheter Cardiovasc Interv. 2014 May 1;83(6):864-72. doi: 10.1002/ccd.25180. Epub 2013 Sep 30.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00552994
IVUS-20070043
Yes
Not Provided
Not Provided
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