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

• Status: Unknown status
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Collaborators: Herzzentrum Bad Krotzingen; Humboldt-Universität zu Berlin; University of Greifswald

Criteria

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