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

Phase 4

Completed

• Conditions: Arterial Occlusive Diseases
• Interventions: Device: Implantation of YUKON Sirolimus-eluting Stent; Device: Implantation of YUKON Stent (uncoated)

• Registration Number: NCT00664963
• Lead Sponsor: Herz-Zentrums Bad Krozingen

Brief Summary

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

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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-23
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Implantation of YUKON Sirolimus-eluting Stent	YUKON Sirolimus-eluting Stent
2	Implantation of YUKON Stent (uncoated)	YUKON Stent (uncoated)

Primary Outcome Measures

Name	Time	Method
Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)	12 months

Secondary Outcome Measures

Name	Time	Method
Number of reinterventions of target vessel	12 months

Trial Locations

Locations (3)

Herz-Zentrums Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

University Hospital of Tübingen; 🇩🇪 Tübingen, Germany