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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00396929
Study type Interventional
Source University Hospital Tuebingen
Contact
Status Active, not recruiting
Phase Phase 3
Start date August 2005
Completion date July 2007

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