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

Sponsors and Collaborators:	University Hospital Tuebingen Herzzentrum Bad Krotzingen Humboldt-Universität zu Berlin
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00156624

Purpose

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.

Condition	Intervention	Phase
Arterial Occlusive Diseases	Drug: Balloon Angioplasty with or without drug administration	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder – Trial)

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Late lumen loss of vessel segment following dilatation after 6 months

Secondary Outcome Measures:

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

Estimated Enrollment:	135
Study Start Date:	July 2004
Estimated Study Completion Date:	October 2007

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

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156624

Locations

Germany
University Hospital of Tuebingen
Tuebingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Herzzentrum Bad Krotzingen

Humboldt-Universität zu Berlin

Investigators

Principal Investigator:	Gunnar Tepe, MD	University Hospital of Tuebingen
Principal Investigator:	Gunnar Tepe, MD	University Hospital of Tuebingen
Principal Investigator:	Gunnar Tepe, MD	University Hospital Tuebingen

More Information

Publications indexed to this study:

Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder 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.

Study ID Numbers:	Pac-2
Study First Received:	September 7, 2005
Last Updated:	April 24, 2006
ClinicalTrials.gov Identifier:	NCT00156624
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

Intervention
Peripheral Vascular Disease
Drug
Restenosis
18 years and above

Study placed in the following topic categories:

Arterial Occlusive Diseases
Peripheral Vascular Diseases
Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009