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CompletedNCT00664963YUKON-BTKUpdated Dec 17, 2014

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

A Phase 4 interventional study of Implantation of YUKON Sirolimus-eluting Stent and Implantation of YUKON Stent (uncoated) in Arterial Occlusive Diseases, sponsored by Herz-Zentrums Bad Krozingen. Completed at 3 sites in Germany. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-12-17.

Sponsored by Herz-Zentrums Bad Krozingen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
21 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Arterial Occlusive Diseases

Keywords

  • Arterial Occlusive Diseases
  • Peripheral Vascular Diseases
  • Drug eluting stent
  • Restenosis
  • Below the knee
  • Intervention
03

In context

Arterial Occlusive Diseases

296 studies on the registry are indexed under Arterial Occlusive Diseases; 46 are open to participants now.

This study's enrollment of 130 is close to the median of 121 across 200 interventional studies indexed under Arterial Occlusive Diseases.

Browse Arterial Occlusive Diseases studies →

Lead sponsor

Herz-Zentrums Bad Krozingen is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Coagulation disorder
  • Known allergy to contrast medium
  • Contraindications to antiplatelet therapy or heparin
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    1

    YUKON Sirolimus-eluting Stent

    Device: Implantation of YUKON Sirolimus-eluting Stent

  • Active comparator
    2

    YUKON Stent (uncoated)

    Device: Implantation of YUKON Stent (uncoated)

Interventions

  • DeviceImplantation of YUKON Sirolimus-eluting Stent

    Implantation of YUKON Sirolimus-eluting Stent

  • DeviceImplantation of YUKON Stent (uncoated)

    Implantation of YUKON Stent (uncoated)

06

What researchers measure

Primary outcomes

  1. Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)

    Time frame: 12 months

Secondary outcomes

  1. Number of reinterventions of target vessel

    Time frame: 12 months

07

Study locations

3 sites
  • Herz-Zentrums Bad Krozingen
    Bad Krozingen, 79189, Germany
  • Universitäres Herzzentrum Hamburg
    Hamburg, 22527, Germany
  • University Hospital of Tübingen
    Tübingen, 72076, Germany
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References and documents

Publications

  • 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. PubMed 22878166 ↗
  • 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. PubMed 21622669 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00664963
Lead sponsor
Herz-Zentrums Bad Krozingen
Responsible party
Prof. Dr. med. Thomas Zeller (Prof., Herz-Zentrums Bad Krozingen) — Principal investigator
First posted
Apr 23, 2008
Start date
Apr 2006
Primary completion
Mar 2010
Completion
Apr 2010
Last update
Dec 17, 2014

Study contacts

Thomas Zeller, MD
principal investigator · Herz-Zentrum Bad Krozingen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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