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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Cypher Select plus; Device: Xience V stent

• Registration Number: NCT00552994
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-10-31
• Study First Posted: 2007-11-02
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-08
• Last Update Submitted: 2010-07-09
• Last Update Posted: 2010-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Cypher Select plus	Cypher Select plus stent
2	Xience V stent	Xience V stent

Primary Outcome Measures

Name	Time	Method
In stent neointimal hyperplasia	Within 10 months

Secondary Outcome Measures

Name	Time	Method
Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss	Within 10 months

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark