NCT00396929

Efficiency of a New Therapy to Treat Stenosis of Coronary Vessels in Comparison With Two Already Admitted Therapies

Local-Tax Trial: Local Intracoronary Administration of Paclitaxel After Stent Implantation for Prevention of Restenosis in Comparison With Stent Implantation Alone and With Implantation of a Paclitaxel-Eluting Stent

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to examine the efficacy of Paclitaxel injection after a stent implantation in patients with stenosis in native coronary arteries to prevent restenosis in comparision with two admitted therapies.

Detailed description

The aim of the study is to examine whether in patients with stable or instable Angina pectoris and/or documented myocardial ischemia in the presence of de-novo stenosis in native coronary arteries with a degree of stenosis between 50 % and 99 % an additional local administration of paclitaxel after implantation of a conventional stent is superior to the implantation of a conventional stent alone with respect to late lumen loss (LLL). In case of superiority it will be examined whether an additional local administration of paclitaxel after implantation of a conventional stent is not inferior to the implantation of a paclitaxel-eluting stent with respect to late lumen-luss. Is this the case, superiority will be tested.

Conditions

• Stable or Unstable Angina Pectoris
• Myocardial Ischemia

Interventions

Type	Name	Description
DRUG	local intracoronary dosis of Paclitaxel

Timeline

• Start date: 2005-08-01
• Completion: 2007-07-01
• First posted: 2006-11-08
• Last updated: 2007-05-16

Locations

1 site across 1 country: Germany