Viewing Study NCT00396929



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00396929
Status: UNKNOWN
Last Update Posted: 2007-05-16
First Post: 2006-11-07

Brief Title: Efficiency of a New Therapy to Treat Stenosis of Coronary Vessels in Comparison With Two Already Admitted Therapies
Sponsor: University Hospital Tuebingen
Organization: University Hospital Tuebingen

Study Overview

Official Title: 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
Status Verified Date: 2007-05
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 andor 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2005-001481-14 None None None