Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Measure
Late lumen loss of vessel segment following dilatation after 6 months
time frame:

Secondary Outcomes

Measure
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)
time frame:
Paclitaxel plasma concentration will be determined immediately after administration
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2006.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.