Treatment of Symptomatic Ischemic Heart Disease Clinical Trial
Official title:
The European Cobalt STent With Antiproliferative for Restenosis Trial (EuroSTAR Trial)
Two consecutive cohorts of subjects were each treated with the CoStar stent loaded with a
different paclitaxel dose regimen. The first 145 subjects (Arm I), enrolled between 20
January 2004 and 26 May 2004, were treated with 10 µg paclitaxel and the subsequent 137
subjects (Arm II), enrolled between 15 December 2004 and 9 March 2005, were treated with 30
µg paclitaxel. Both dose formulations eluted over 30 days (in-vitro).
Subjects in both arms completed clinical follow-up at 1, 6 and 12 months post-index
procedure, with angiographic follow-up at 6 months as outlined in the original study
protocol.
Based on results from previous studies and the initial EuroSTAR Trial results, Conor
Medsystems decided to pursue the dosage used in Arm I, 10 μg/30 days, as the commercial dose
formulation for the CoStar® stent. The EuroSTAR Trial addendum was proposed for the purpose
of evaluating the long-term clinical outcomes of the CoStar stent.
The EuroSTAR Trial (European Cobalt STent with Antiproliferative for Restenosis Trial) is a prospective, multi-center, two-arm study to evaluate the safety and performance of the CoStar® stent for the treatment of symptomatic ischemic heart disease attributable to stenotic de novo lesions of the native coronary arteries that are amenable to treatment by percutaneous stenting. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment