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

December 16, 2014 updated by: Prof. Dr. med. Thomas Zeller, Herz-Zentrums Bad Krozingen

YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Krozingen, Germany, 79189
        • Herz-Zentrums Bad Krozingen
      • Hamburg, Germany, 22527
        • Universitäres Herzzentrum Hamburg
      • Tübingen, Germany, 72076
        • University Hospital of Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of reinterventions of target vessel
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herz-Zentrums Bad Krozingen

Investigators

  • Principal Investigator: Thomas Zeller, MD, Herz-Zentrum Bad Krozingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YUKON-BTK v3.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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