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Sponsors and Collaborators: |
University Hospital Tuebingen Herzzentrum Bad Krotzingen Humboldt-Universität zu Berlin |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00156624 |
The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.
Condition | Intervention | Phase |
---|---|---|
Arterial Occlusive Diseases |
Drug: Balloon Angioplasty with or without drug administration |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder – Trial) |
Estimated Enrollment: | 135 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | October 2007 |
Drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries. Unfortunately drug eluting stents failed to demonstrate superiority over bare stents in the superficial femoral artery. We could show that a non-stent based delivery of Taxan was equal or superior to drug eluting stents in an animal model. This was both true for the coronary arteries and peripheral vessels.
In a prospective blinded trail >135 patients are randomized either to receive Taxan locally administered with a balloon catheter during balloon angioplasty, or together with contrast media. One group serves as control. There were no limitations due to lesion length. Follow-up angiography will be after 6 months, 12 months and 2 years.
Ages Eligible for Study: | 18 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
University Hospital of Tuebingen | |
Tuebingen, Germany, 72076 |
Principal Investigator: | Gunnar Tepe, MD | University Hospital of Tuebingen |
Principal Investigator: | Gunnar Tepe, MD | University Hospital of Tuebingen |
Principal Investigator: | Gunnar Tepe, MD | University Hospital Tuebingen |
Study ID Numbers: | Pac-2 |
Study First Received: | September 7, 2005 |
Last Updated: | April 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00156624 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Intervention Peripheral Vascular Disease Drug Restenosis 18 years and above |
Arterial Occlusive Diseases Peripheral Vascular Diseases Vascular Diseases |
Cardiovascular Diseases |