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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital Tuebingen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Herzzentrum Bad Krotzingen
Humboldt-Universität zu Berlin
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00156624
First received: September 7, 2005
Last updated: April 24, 2006
Last verified: September 2005
  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
Endpoint Classification: Safety/Efficacy Study
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Tuebingen
  More Information

No publications provided by University Hospital Tuebingen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00156624     History of Changes
Other Study ID Numbers: Pac-2
Study First Received: September 7, 2005
Last Updated: April 24, 2006
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

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014