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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
  Purpose

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


Condition Intervention
Diabetes Mellitus
 Device: Cypher Select plus
Device: Xience V stent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • In stent neointimal hyperplasia [ Time Frame: Within 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: August 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Lisette Okkels Jensen, Odense University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00552994     History of Changes
Other Study ID Numbers: IVUS-20070043
Study First Received: October 31, 2007
Last Updated: July 9, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013