Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries
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|ClinicalTrials.gov Identifier: NCT00156624|
Recruitment Status : Unknown
Verified September 2005 by University Hospital Tuebingen.
Recruitment status was: Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : April 25, 2006
|Condition or disease||Intervention/treatment||Phase|
|Arterial Occlusive Diseases||Drug: Balloon Angioplasty with or without drug administration||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder – Trial)|
|Study Start Date :||July 2004|
|Study Completion Date :||October 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156624
|University Hospital of Tuebingen|
|Tuebingen, Germany, 72076|
|Principal Investigator:||Gunnar Tepe, MD||University Hospital of Tuebingen|
|Principal Investigator:||Gunnar Tepe, MD||University Hospital Tuebingen|