Back to results

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

Primary Purpose

Arterial Occlusive Diseases

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Implantation of YUKON Sirolimus-eluting Stent

Implantation of YUKON Stent (uncoated)

About this trial

This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring Arterial Occlusive Diseases, Peripheral Vascular Diseases, Drug eluting stent, Restenosis, Below the knee, Intervention

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Herz-Zentrums Bad Krozingen
Universitäres Herzzentrum Hamburg
University Hospital of Tübingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

YUKON Sirolimus-eluting Stent

YUKON Stent (uncoated)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of reinterventions of target vessel

Full Information

NCT ID

NCT00664963

First Posted

April 18, 2008

Last Updated

December 16, 2014

Sponsor

Herz-Zentrums Bad Krozingen

1. Study Identification

Unique Protocol Identification Number

NCT00664963

Brief Title

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

Acronym

YUKON-BTK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Herz-Zentrums Bad Krozingen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arterial Occlusive Diseases

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

YUKON Sirolimus-eluting Stent

Arm Title

Arm Type

Active Comparator

Arm Description

YUKON Stent (uncoated)

Intervention Type

Device

Intervention Name(s)

Implantation of YUKON Sirolimus-eluting Stent

Intervention Description

Implantation of YUKON Sirolimus-eluting Stent

Intervention Type

Device

Intervention Name(s)

Implantation of YUKON Stent (uncoated)

Intervention Description

Implantation of YUKON Stent (uncoated)

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of reinterventions of target vessel

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Zeller, MD

Organizational Affiliation

Herz-Zentrum Bad Krozingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herz-Zentrums Bad Krozingen

City

Bad Krozingen

ZIP/Postal Code

79189

Country

Germany

Facility Name

Universitäres Herzzentrum Hamburg

City

Hamburg

ZIP/Postal Code

22527

Country

Germany

Facility Name

University Hospital of Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

22878166

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.

Results Reference

derived

PubMed Identifier

21622669

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs