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

Phase 2

• Conditions: Arterial Occlusive Diseases

• Registration Number: NCT00156624
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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

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 Timeline

• Study Start: 2004-07
• Status Verified: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Last Update Submitted: 2006-04-24
• Last Update Posted: 2006-04-25
• Study Completion: 2007-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Late lumen loss of vessel segment following dilatation after 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital of Tuebingen; 🇩🇪 Tuebingen, Germany