Arterial Occlusive Diseases
Conditions
Keywords
Intervention, Peripheral Vascular Disease, Drug, Restenosis, 18 years and above
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.
Interventions
Sponsors
Herzzentrum Bad Krotzingen
Humboldt-Universität zu Berlin
University of Greifswald
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss of vessel segment following dilatation after 6 months | — |
Secondary
| Measure | 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 | — |
Countries
Germany
Outcome results
None listed