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

Arterial Occlusive Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00156624
• Other study ID #: Pac-2
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 7, 2005
• Last updated: April 24, 2006
• Start date: July 2004
• Est. completion date: October 2007

Study information

• Verified date: September 2005
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 135
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

Drug:
• Balloon Angioplasty with or without drug administration

Locations

Country	Name	City	State
Germany	University Hospital of Tuebingen	Tuebingen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Herzzentrum Bad Krotzingen, Humboldt-Universität zu Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumen loss of vessel segment following dilatation after 6 months
Secondary	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)
Secondary	Paclitaxel plasma concentration will be determined immediately after administration