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Search / Trial NCT00664963

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

Launched by HERZ-ZENTRUMS BAD KROZINGEN · Apr 18, 2008

Trial Information

Current as of August 02, 2025

Completed

Keywords

Arterial Occlusive Diseases Peripheral Vascular Diseases Drug Eluting Stent Restenosis Below The Knee Intervention

ClinConnect Summary

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...

Gender

ALL

Eligibility 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

About Herz Zentrums Bad Krozingen

Herz-Zentrum Bad Krozingen is a leading clinical research institution specializing in cardiovascular medicine. Renowned for its commitment to advancing heart health, the center focuses on innovative treatments and therapies through rigorous clinical trials. With a multidisciplinary team of expert cardiologists, researchers, and healthcare professionals, Herz-Zentrum Bad Krozingen aims to enhance patient outcomes by integrating cutting-edge research with compassionate care. The center plays a pivotal role in contributing to the global knowledge base in cardiology, fostering collaboration with academic institutions and industry partners to drive forward the future of cardiovascular health.

Locations

Tübingen, , Germany

Bad Krozingen, , Germany

Hamburg, , Germany

Patients applied

0 patients applied

Trial Officials

Thomas Zeller, MD

Principal Investigator

Herz-Zentrum Bad Krozingen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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