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YUKON-Drug-Eluting Stent Below The Knee - Randomised Double-Blind Study (YUKON-BTK)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Herz-Zentrums Bad Krozingen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier:
NCT00664963
First received: April 18, 2008
Last updated: February 9, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Arterial Occlusive Diseases
 Device: Implantation of YUKON Sirolimus-eluting Stent
Device: Implantation of YUKON Stent (uncoated)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: YUKON-Drug-Eluting Stent Below The Knee - Prospective Randomized Double-Blind Multicenter Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herz-Zentrums Bad Krozingen:

Primary Outcome Measures:
  • Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of reinterventions of target vessel [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: April 2006
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
YUKON Sirolimus-eluting Stent
 Device: Implantation of YUKON Sirolimus-eluting Stent
Implantation of YUKON Sirolimus-eluting Stent
Active Comparator: 2
YUKON Stent (uncoated)
 Device: Implantation of YUKON Stent (uncoated)
Implantation of YUKON Stent (uncoated)

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664963

Locations
Germany
Herz-Zentrums Bad Krozingen
Bad Krozingen, Germany, 79189
Universitäres Herzzentrum Hamburg
Hamburg, Germany, 22527
University Hospital of Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
Herz-Zentrums Bad Krozingen
Investigators
Principal Investigator: Thomas Zeller, MD Herz-Zentrum Bad Krozingen
  More Information

No publications provided by Herz-Zentrums Bad Krozingen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier: NCT00664963     History of Changes
Other Study ID Numbers: YUKON-BTK v3.0
Study First Received: April 18, 2008
Last Updated: February 9, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Herz-Zentrums Bad Krozingen:
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Drug eluting stent
 Restenosis
Below the knee
Intervention

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013