Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder - Trial)

Conditions
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Arterial Occlusive Diseases

Intervention / Treatment
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* Drug: Balloon Angioplasty with or without drug administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Balloon Angioplasty with or without drug administration|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss of vessel segment following dilatation after 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention, Peripheral Vascular Disease, Drug, Restenosis, 18 years and above