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Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder – Trial)

Phase 2/Phase 3
18 Years
95 Years
Open (Enrolling)
Arterial Occlusive Diseases

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Trial Information

Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder – Trial)

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Late lumen loss of vessel segment following dilatation after 6 months

Principal Investigator

Gunnar Tepe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Tuebingen


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

July 2004

Completion Date:

October 2007

Related Keywords:

  • Arterial Occlusive Diseases
  • Intervention
  • Peripheral Vascular Disease
  • Drug
  • Restenosis
  • 18 years and above
  • Arterial Occlusive Diseases