Status:
UNKNOWN
Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Herzzentrum Bad Krotzingen
Humboldt-Universität zu Berlin
Conditions:
Arterial Occlusive Diseases
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
PHASE3
Brief Summary
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 arter...
Detailed Description
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 fem...
Eligibility Criteria
Inclusion
- Adults
- Chronic Occlusions and stenosis (history at least 6 weeks) ≥70 % diameter Stenosis \> 2cm in the arteria femoralis superficialis or arteria poplitea
- Various criteria assuring ethical issues and follow up
Exclusion
- Conditions requiring different treatment or raising serious safety concern regarding the procedure or the required medication.
- Pregnancy can not be excluded
- Doubts in the willingness or capability of the patient to allow 6 months follow up
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00156624
Start Date
July 1 2004
End Date
October 1 2007
Last Update
April 25 2006
Active Locations (1)
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1
University Hospital of Tuebingen
Tübingen, Germany, 72076