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

Arterial Occlusive Diseases Clinical Trial

— YUKON-BTK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664963
• Other study ID #: YUKON-BTK v3.0
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2008
• Last updated: December 16, 2014
• Start date: April 2006
• Est. completion date: April 2010

Study information

• Verified date: December 2014
• Source: Herz-Zentrums Bad Krozingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

Device:
• Implantation of YUKON Sirolimus-eluting Stent
Implantation of YUKON Sirolimus-eluting Stent
• Implantation of YUKON Stent (uncoated)
Implantation of YUKON Stent (uncoated)

Locations

Country	Name	City	State
Germany	Herz-Zentrums Bad Krozingen	Bad Krozingen
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	University Hospital of Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Herz-Zentrums Bad Krozingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)		12 months	No
Secondary	Number of reinterventions of target vessel		12 months	No