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

NCT ID: NCT00664963

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Arterial Occlusive Diseases

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

YUKON Sirolimus-eluting Stent

Group Type EXPERIMENTAL

Implantation of YUKON Sirolimus-eluting Stent

Intervention Type DEVICE

Implantation of YUKON Sirolimus-eluting Stent

2

YUKON Stent (uncoated)

Group Type ACTIVE_COMPARATOR

Implantation of YUKON Stent (uncoated)

Intervention Type DEVICE

Implantation of YUKON Stent (uncoated)

Interventions

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Implantation of YUKON Sirolimus-eluting Stent

Implantation of YUKON Sirolimus-eluting Stent

Intervention Type DEVICE

Implantation of YUKON Stent (uncoated)

Implantation of YUKON Stent (uncoated)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herz-Zentrums Bad Krozingen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Thomas Zeller

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Zeller, MD

Role: PRINCIPAL_INVESTIGATOR

Herz-Zentrum Bad Krozingen

Locations

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Herz-Zentrums Bad Krozingen

Bad Krozingen, , Germany

Site Status

Universitäres Herzzentrum Hamburg

Hamburg, , Germany

Site Status

University Hospital of Tübingen

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 22878166 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21622669 (View on PubMed)

Other Identifiers

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YUKON-BTK v3.0

Identifier Type: -

Identifier Source: org_study_id