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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Hospital Tuebingen.
Recruitment status was:  Active, not recruiting
Herzzentrum Bad Krotzingen
Humboldt-Universität zu Berlin
Information provided by:
University Hospital Tuebingen Identifier:
First received: September 7, 2005
Last updated: April 24, 2006
Last verified: September 2005
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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00156624

University Hospital of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Herzzentrum Bad Krotzingen
Humboldt-Universität zu Berlin
Principal Investigator: Gunnar Tepe, MD University Hospital of Tuebingen
Principal Investigator: Gunnar Tepe, MD University Hospital Tuebingen