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

Odense University Hospital

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Xience V stent; Device: Cypher Select plus

Study type: Interventional

Funder types: Other

Identifiers

NCT00552994

IVUS-20070043

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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150 participants in 2 patient groups

1

Active Comparator group

Description:

Cypher Select plus stent

Treatment:

Device: Cypher Select plus

2

Active Comparator group

Description:

Xience V stent

Treatment:

Device: Xience V stent