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

University Hospital Tuebingen

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Arterial Occlusive Diseases

Treatments

Drug: Balloon Angioplasty with or without drug administration

Study type

Interventional

Funder types

Other

Identifiers

NCT00156624

Pac-2

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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