Trial | NCT00156624  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    paclitaxel ...

  • Study Participants

    135
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.
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.
Study Started
Jul 31
2004
Study Completion
Oct 31
2007
Last Update
Apr 25
2006
Estimate

Drug Balloon Angioplasty with or without drug administration

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
No Results Posted