Comparison of Coronary Xience V and the Cypher Select+ Stents in Diabetic Patients

Diabetes Mellitus Clinical Trial

— DIABEDES IV  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552994
• Other study ID #: IVUS-20070043
• Status: Completed
• Phase: N/A
• First received: October 31, 2007
• Last updated: July 9, 2010
• Start date: August 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Cypher Select plus
Drug eluting stent
• Xience V stent
Drug eluting stent

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In stent neointimal hyperplasia		Within 10 months	No
Secondary	Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss		Within 10 months	No