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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arterial Occlusive Diseases

Intervention / Treatment
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* Device: Implantation of YUKON Sirolimus-eluting Stent
* Device: Implantation of YUKON Stent (uncoated)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>YUKON Sirolimus-eluting Stent | Device: Implantation of YUKON Sirolimus-eluting Stent<br>* Implantation of YUKON Sirolimus-eluting Stent<br>|
| Active Comparator: 2<br>YUKON Stent (uncoated) | Device: Implantation of YUKON Stent (uncoated)<br>* Implantation of YUKON Stent (uncoated)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of reinterventions of target vessel |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arterial Occlusive Diseases, Peripheral Vascular Diseases, Drug eluting stent, Restenosis, Below the knee, Intervention