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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014