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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00552994

Acronym

DIABEDES IV

Enrollment

150

Registered

2007-11-02

Start date

2007-08-31

Completion date

2009-07-31

Last updated

2010-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Drug eluting stent, Diabetics, Intravascular ultrasound, Pathophysiologic (neointimal hyperplasia and peri-stent remodeling)

Brief summary

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

Interventions

DEVICECypher Select plus

Drug eluting stent

DEVICEXience V stent

Drug eluting stent

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
In stent neointimal hyperplasia	Within 10 months

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026