YUKON-Drug-Eluting Stent Below The Knee - Randomised Double-Blind Study (YUKON-BTK)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Herz-Zentrums Bad Krozingen.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Herz-Zentrums Bad Krozingen

ClinicalTrials.gov Identifier:

NCT00664963

First received: April 18, 2008

Last updated: February 9, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 18, 2008

Last Updated Date

February 9, 2009

Start Date ^ICMJE

April 2006

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00664963 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

YUKON-Drug-Eluting Stent Below The Knee - Prospective Randomized Double-Blind Multicenter Study

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Arterial Occlusive Diseases

Intervention ^ICMJE

Device: Implantation of YUKON Sirolimus-eluting Stent
Implantation of YUKON Sirolimus-eluting Stent
Device: Implantation of YUKON Stent (uncoated)
Implantation of YUKON Stent (uncoated)

Study Arm (s)

Experimental: 1
YUKON Sirolimus-eluting Stent

Intervention: Device: Implantation of YUKON Sirolimus-eluting Stent
Active Comparator: 2
YUKON Stent (uncoated)

Intervention: Device: Implantation of YUKON Stent (uncoated)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

130

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00664963

Other Study ID Numbers ^ICMJE

YUKON-BTK v3.0

Has Data Monitoring Committee

Responsible Party

Herz-Zentrums Bad Krozingen

Study Sponsor ^ICMJE

Herz-Zentrums Bad Krozingen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thomas Zeller, MD

Herz-Zentrum Bad Krozingen

Information Provided By

Herz-Zentrums Bad Krozingen

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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