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Sponsored by: |
Herz-Zentrums Bad Krozingen |
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Information provided by: | Herz-Zentrums Bad Krozingen |
ClinicalTrials.gov Identifier: | NCT00664963 |
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 |
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Arterial Occlusive Diseases |
Device: Implantation of YUKON Sirolimus-eluting Stent Device: Implantation of YUKON Stent (uncoated) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | YUKON-Drug-Eluting Stent Below The Knee - Prospective Randomized Double-Blind Multicenter Study |
Estimated Enrollment: | 130 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
YUKON Sirolimus-eluting Stent
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Device: Implantation of YUKON Sirolimus-eluting Stent
Implantation of YUKON Sirolimus-eluting Stent
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2: Active Comparator
YUKON Stent (uncoated)
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Device: Implantation of YUKON Stent (uncoated)
Implantation of YUKON Stent (uncoated)
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas Zeller, MD | +49 (0)7633 402 2431 | thomas.zeller@herzzentrum.de |
Contact: Aljoscha Rastan, MD | +49 (0)7633 402 2431 | aljoscha.rastan@herzzentrum.de |
Germany | |
Herz-Zentrums Bad Krozingen | Recruiting |
Bad Krozingen, Germany, 79189 | |
Contact: Thomas Zeller, MD +49 (0)7633 402 2431 thomas.zeller@herzzentrum.de | |
Contact: Kirsten Hauswald, MD +49 (0)7633 402 4366 kirsten.hauswald@herzzentrum.de | |
Principal Investigator: Thomas Zeller, MD | |
University Hospital of Tübingen | Recruiting |
Tübingen, Germany, 72076 | |
Contact: Gunnar Tepe, MD +49 (7071) 298 20 87 gunnar.tepe@med.uni-tuebingen.de | |
Contact: Gunnar Tepe, MD +49 (7071) 298 20 87 gunnar.tepe@med.uni-tuebingen.de | |
Principal Investigator: Gunnar Tepe, MD | |
Universitäres Herzzentrum Hamburg | Active, not recruiting |
Hamburg, Germany, 22527 |
Principal Investigator: | Thomas Zeller, MD | Herz-Zentrum Bad Krozingen |
Responsible Party: | Herz-Zentrums Bad Krozingen ( Herz-Zentrums Bad Krozingen ) |
Study ID Numbers: | YUKON-BTK v3.0 |
Study First Received: | April 18, 2008 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00664963 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Arterial Occlusive Diseases Peripheral Vascular Diseases Drug eluting stent |
Restenosis Below the knee Intervention |
Sirolimus Arterial Occlusive Diseases Peripheral Vascular Diseases Clotrimazole |
Miconazole Tioconazole Vascular Diseases |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |