YUKON-drug-eluting Stent Below The Knee - Randomised Double-blind Study
YUKON-BTK
1 other identifier
interventional
130
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2006
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 18, 2008
CompletedFirst Posted
Study publicly available on registry
April 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedDecember 17, 2014
December 1, 2014
3.9 years
April 18, 2008
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)
12 months
Secondary Outcomes (1)
Number of reinterventions of target vessel
12 months
Study Arms (2)
1
EXPERIMENTALYUKON Sirolimus-eluting Stent
2
ACTIVE COMPARATORYUKON Stent (uncoated)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Coagulation disorder
- Known allergy to contrast medium
- Contraindications to antiplatelet therapy or heparin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Herz-Zentrums Bad Krozingen
Bad Krozingen, 79189, Germany
Universitäres Herzzentrum Hamburg
Hamburg, 22527, Germany
University Hospital of Tübingen
Tübingen, 72076, Germany
Related Publications (2)
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.
PMID: 22878166DERIVEDRastan 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.
PMID: 21622669DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Zeller, MD
Herz-Zentrum Bad Krozingen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
April 18, 2008
First Posted
April 23, 2008
Study Start
April 1, 2006
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
December 17, 2014
Record last verified: 2014-12