NCT00156624

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 135 (planned)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arterial Occlusive Diseases

Interventions

Type	Name	Description
DRUG	Balloon Angioplasty with or without drug administration

Timeline

• Start date: 2004-07-01
• Completion: 2007-10-01
• First posted: 2005-09-12
• Last updated: 2006-04-25

Locations

1 site across 1 country: Germany