YUKON-Drug-Eluting Stent Below The Knee - Randomised Double-Blind Study - Full Text View

Sponsored by:	Herz-Zentrums Bad Krozingen
Information provided by:	Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier:	NCT00664963

Purpose

The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease.

Condition	Intervention	Phase
Arterial Occlusive Diseases	Device: Implantation of YUKON Sirolimus-eluting Stent Device: Implantation of YUKON Stent (uncoated)	Phase IV

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	YUKON-Drug-Eluting Stent Below The Knee - Prospective Randomized Double-Blind Multicenter Study

Further study details as provided by Herz-Zentrums Bad Krozingen:

Primary Outcome Measures:

Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of reinterventions of target vessel [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	April 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental YUKON Sirolimus-eluting Stent	Device: Implantation of YUKON Sirolimus-eluting Stent Implantation of YUKON Sirolimus-eluting Stent
2: Active Comparator YUKON Stent (uncoated)	Device: Implantation of YUKON Stent (uncoated) Implantation of YUKON Stent (uncoated)

Detailed Description:

Based on the fact that drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries, we assume that YUKON-BTX-Sirolimus-eluting stent has a superior restenosis rate compared to treatment with uncoated stent in the below-the-knee arteries consecutively. The purpose of this study is to compare the restenosis rate of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease. Randomisation will be performed by extremity, that may lead to varying treatments within one patient during the study.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of peripheral arterial occlusive disease as defined by Rutherford 2-5
De-novo stenosis of > 70% diameter stenosis in the tibioperoneal trunc, anterior and/or posterior tibial and/or peroneal artery
Target lesion length of ≤ 45 mm

Exclusion Criteria:

Coagulation disorder
Known allergy to contrast medium
Contraindications to antiplatelet therapy or heparin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664963

Contacts

Contact: Thomas Zeller, MD	+49 (0)7633 402 2431	thomas.zeller@herzzentrum.de
Contact: Aljoscha Rastan, MD	+49 (0)7633 402 2431	aljoscha.rastan@herzzentrum.de

Locations

Germany
Herz-Zentrums Bad Krozingen	Recruiting
Bad Krozingen, Germany, 79189
Contact: Thomas Zeller, MD +49 (0)7633 402 2431 thomas.zeller@herzzentrum.de
Contact: Kirsten Hauswald, MD +49 (0)7633 402 4366 kirsten.hauswald@herzzentrum.de
Principal Investigator: Thomas Zeller, MD
University Hospital of Tübingen	Recruiting
Tübingen, Germany, 72076
Contact: Gunnar Tepe, MD +49 (7071) 298 20 87 gunnar.tepe@med.uni-tuebingen.de
Contact: Gunnar Tepe, MD +49 (7071) 298 20 87 gunnar.tepe@med.uni-tuebingen.de
Principal Investigator: Gunnar Tepe, MD
Universitäres Herzzentrum Hamburg	Active, not recruiting
Hamburg, Germany, 22527

Sponsors and Collaborators

Herz-Zentrums Bad Krozingen

Investigators

Principal Investigator:

Thomas Zeller, MD

Herz-Zentrum Bad Krozingen

More Information

Responsible Party:	Herz-Zentrums Bad Krozingen ( Herz-Zentrums Bad Krozingen )
Study ID Numbers:	YUKON-BTK v3.0
Study First Received:	April 18, 2008
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00664963
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Herz-Zentrums Bad Krozingen:

Arterial Occlusive Diseases
Peripheral Vascular Diseases
Drug eluting stent

Restenosis
Below the knee
Intervention

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Clotrimazole

Miconazole
Tioconazole
Vascular Diseases

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009