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

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ClinicalTrials.gov Identifier: NCT00552994
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : July 12, 2010
Sponsor:
Information provided by:
Odense University Hospital

Brief Summary:
In stent neointimal hyperplasia may be less in the Cypher select plus stent compared to the Xience V stent in diabetic patients.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Cypher Select plus Device: Xience V stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : August 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Active Comparator: 1
Cypher Select plus stent
Device: Cypher Select plus
Drug eluting stent

Active Comparator: 2
Xience V stent
Device: Xience V stent
Drug eluting stent




Primary Outcome Measures :
  1. In stent neointimal hyperplasia [ Time Frame: Within 10 months ]

Secondary Outcome Measures :
  1. Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss [ Time Frame: Within 10 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00552994


Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Per Thayssen, MD DMSci Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisette Okkels Jensen, Odense University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00552994     History of Changes
Other Study ID Numbers: IVUS-20070043
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: August 2009

Keywords provided by Odense University Hospital:
Drug eluting stent
Diabetics
Intravascular ultrasound
Pathophysiologic (neointimal hyperplasia and peri-stent remodeling)

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases