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Completed

NCT Number: NCT00664963

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

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Key information

Conditions

Arterial Occlusive Diseases Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Herz-Zentrums Bad Krozingen, Bad Krozingen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of YUKON Sirolimus-eluting Stent

Device

Implantation of YUKON Sirolimus-eluting Stent

Implantation of YUKON Stent (uncoated)

Device

Implantation of YUKON Stent (uncoated)

Primary outcomes

  1. Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)

    Time frame: 12 months

Secondary outcomes

  1. Number of reinterventions of target vessel

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Herz-Zentrums Bad Krozingen

Other

Registry information

Official study title

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

Acronym: YUKON-BTK

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Apr 23, 2008
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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