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

Herz-Zentrums Bad Krozingen

Status and phase

Completed

Phase 4

Conditions

Arterial Occlusive Diseases

Treatments

Device: Implantation of YUKON Sirolimus-eluting Stent

Device: Implantation of YUKON Stent (uncoated)

Study type

Interventional

Funder types

Other

Identifiers

NCT00664963

YUKON-BTK v3.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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