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YUKON-drug-eluting Stent Below The Knee - Randomised Double-blind Study (YUKON-BTK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664963
First Posted: April 23, 2008
Last Update Posted: December 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Dr. med. Thomas Zeller, Herz-Zentrums Bad Krozingen
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study

Resource links provided by NLM:


Further study details as provided by Prof. Dr. med. Thomas Zeller, Herz-Zentrums Bad Krozingen:

Primary Outcome Measures:
  • Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Number of reinterventions of target vessel [ Time Frame: 12 months ]

Enrollment: 130
Study Start Date: April 2006
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
YUKON Sirolimus-eluting Stent
Device: Implantation of YUKON Sirolimus-eluting Stent
Implantation of YUKON Sirolimus-eluting Stent
Active Comparator: 2
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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664963


Locations
Germany
Herz-Zentrums Bad Krozingen
Bad Krozingen, Germany, 79189
Universitäres Herzzentrum Hamburg
Hamburg, Germany, 22527
University Hospital of Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
Herz-Zentrums Bad Krozingen
Investigators
Principal Investigator: Thomas Zeller, MD Herz-Zentrum Bad Krozingen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Thomas Zeller, Prof., Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier: NCT00664963     History of Changes
Other Study ID Numbers: YUKON-BTK v3.0
First Submitted: April 18, 2008
First Posted: April 23, 2008
Last Update Posted: December 17, 2014
Last Verified: December 2014

Keywords provided by Prof. Dr. med. Thomas Zeller, Herz-Zentrums Bad Krozingen:
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Drug eluting stent
Restenosis
Below the knee
Intervention

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs