Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries
This trial is active, not recruiting.
|Condition||arterial occlusive diseases|
|Treatment||balloon angioplasty with or without drug administration|
|Phase||phase 2/phase 3|
|Sponsor||University Hospital Tuebingen|
|Collaborator||Herzzentrum Bad Krotzingen|
|Start date||July 2004|
|End date||October 2007|
|Trial size||135 participants|
|Trial identifier||NCT00156624, Pac-2|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
Male or female participants from 18 years up to 95 years old.
Inclusion Criteria: - 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 Criteria: - 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
|Official title||Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder – Trial)|
|Principal investigator||Gunnar Tepe, MD|
|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 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.|
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