Arterial Occlusive Diseases Clinical Trial
Official title:
Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder – Trial)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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