Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries
Recruitment status was Active, not recruiting
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.
Arterial Occlusive Diseases
Drug: Balloon Angioplasty with or without drug administration
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder – Trial)|
- Late lumen loss of vessel segment following dilatation after 6 months
- Thrombotic complications or revascularization of the target vessel, death; adverse reactions known to occur after paclitaxel (high dose tumor therapy except reactions to the detergent)
- Paclitaxel plasma concentration will be determined immediately after administration
|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.
|University Hospital of Tuebingen|
|Tuebingen, Germany, 72076|
|Principal Investigator:||Gunnar Tepe, MD||University Hospital of Tuebingen|
|Principal Investigator:||Gunnar Tepe, MD||University Hospital Tuebingen|