Comparison of Coronary Xience V and the Cypher Select+ Stents in Diabetic Patients - Full Text View

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

This study is currently recruiting participants.
Verified by Odense University Hospital, October 2007

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00552994

Purpose

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

Condition	Intervention
Diabetes Mellitus	Device: Cypher Select plus Device: Xience V stent

MedlinePlus related topics:

Diabetes Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment

Official Title:	A Danish Prospectiv Randomized Multicenter Comparison of the Xience V and the Cypher Select+ Stents in Unselective Patients With Diabetes Mellitus. An Intravascular Ultrasound Study.

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

In stent neointimal hyperplasia [ Time Frame: within 10 months ]

Secondary Outcome Measures:

Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss [ Time Frame: Within 10 months ]

Estimated Enrollment:	150
Study Start Date:	August 2007
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Active Comparator Cypher Select plus stent	Device: Cypher Select plus Drug eluting stent
2: Active Comparator Xience V stent	Device: Xience V stent Drug eluting stent

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552994

Contacts


Contact: Lisette Okkels Jensen, MD PhD	004565412690	okkels@dadlnet.dk

Contact: Per Thayssen, MD DMSci	004565412681	per.thayssen@ouh.regionsyddanmark.dk

Locations


Denmark
	Odense University Hospital	Recruiting
	Odense, Denmark, 5000
	Contact: Per Thayssen, MD DMSci 004565412681 per.thayssen@ouh.regionsyddanmark.dk

Sponsors and Collaborators

Odense University Hospital

Investigators


Principal Investigator:	Per Thayssen, MD DMSci	Odense University Hospital

More Information

Study ID Numbers:	IVUS-20070043
First Received:	October 31, 2007
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00552994
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee

Keywords provided by Odense University Hospital:

Drug eluting stent

Diabetics

Intravascular ultrasound

Pathophysiologic (neointimal hyperplasia and peri-stent remodeling)

Study placed in the following topic categories:

Hyperplasia

Metabolic Diseases

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 07, 2008