Clinical trial NCT00664963: YUKON-drug-eluting Stent Below The Knee - Randomised Double-blind Study
Official title: YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arterial Occlusive Diseases
Keywords: Arterial Occlusive Diseases
Peripheral Vascular Diseases
Drug eluting stent
Restenosis
Below the knee
Intervention
Lead sponsor: Herz-Zentrums Bad Krozingen
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 130
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)
timeFrame: 12 months
Secondary outcomes:
measure: Number of reinterventions of target vessel
timeFrame: 12 months
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herz-Zentrums Bad Krozingen
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Tübingen
country: Germany
facility: University Hospital of Tübingen
Study officials:
affiliation: Herz-Zentrum Bad Krozingen
name: Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rastan A, Brechtel K, Krankenberg H, Zahorsky R, Tepe G, Noory E, Schwarzwalder U, Macharzina R, Schwarz T, Burgelin K, Sixt S, Tubler T, Neumann FJ, Zeller T. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial. J Am Coll Cardiol. 2012 Aug 14;60(7):587-91. doi: 10.1016/j.jacc.2012.04.035.
citation: Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, Sixt S, Schwarz T, Brechtel K, Bohme C, Neumann FJ, Zeller T. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011 Sep;32(18):2274-81. doi: 10.1093/eurheartj/ehr144. Epub 2011 May 26.