Clinical trial NCT00156624: Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries
Official title: Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder - Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Arterial Occlusive Diseases
Keywords: Intervention
Peripheral Vascular Disease
Drug
Restenosis
18 years and above
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Herzzentrum Bad Krotzingen
name: Humboldt-Universität zu Berlin
name: University of Greifswald
First posted: 2005-09-12
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Late lumen loss of vessel segment following dilatation after 6 months
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)
measure: Paclitaxel plasma concentration will be determined immediately after administration
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital of Tuebingen
Study officials:
affiliation: University Hospital of Tuebingen
name: Gunnar Tepe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tuebingen
name: Gunnar Tepe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tepe G, Schnorr B, Albrecht T, Brechtel K, Claussen CD, Scheller B, Speck U, Zeller T. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):102-8. doi: 10.1016/j.jcin.2014.07.023.
citation: Tepe G, Zeller T, Schnorr B, Claussen CD, Beschorner U, Brechtel K, Scheller B, Speck U. High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther. 2013 Dec;20(6):792-800. doi: 10.1583/13-4392R.1.
citation: Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.