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

NCT ID: NCT00552994

Last Updated: 2010-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Cypher Select plus stent

Group Type ACTIVE_COMPARATOR

Cypher Select plus

Intervention Type DEVICE

Drug eluting stent

2

Xience V stent

Group Type ACTIVE_COMPARATOR

Xience V stent

Intervention Type DEVICE

Drug eluting stent

Interventions

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Cypher Select plus

Drug eluting stent

Intervention Type DEVICE

Xience V stent

Drug eluting stent

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Odense University Hospital, Denmark

Principal Investigators

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Per Thayssen, MD DMSci

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Antonsen L, Maeng M, Thayssen P, Christiansen EH, Hansen KN, Kaltoft A, Hansen HS, Thuesen L, Lassen JF, Jensen LO. Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients: the randomized Diabetes and Drug-Eluting Stent (DiabeDES) IV Intravascular Ultrasound trial. Catheter Cardiovasc Interv. 2014 May 1;83(6):864-72. doi: 10.1002/ccd.25180. Epub 2013 Sep 30.

Reference Type DERIVED
PMID: 23996918 (View on PubMed)

Other Identifiers

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IVUS-20070043

Identifier Type: -

Identifier Source: org_study_id

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