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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00156624
First Posted: September 12, 2005
Last Update Posted: April 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Herzzentrum Bad Krotzingen
Humboldt-Universität zu Berlin
Information provided by:
University Hospital Tuebingen
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Tuebingen