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Clinical Trial Summary

This study is a multicenter, open label, prospective, single arm trial

Single arm group; following angiography, eligible patients with unprotected LMCA stenosis >50% by visual estimation, which is equally treatable by the both treatment strategy (EES stenting or CABG), will be treated with EES


Clinical Trial Description

The primary objective of the PRECOMBAT-2 trial is to establish the safety and effectiveness of coronary stenting with the everolimus-eluting Xience V stent (EES) compared with the historical control (PRE-COMBAT-1) of bypass surgery and sirolimus-eluting stent (SES) for the treatment of an unprotected LMCA stenosis. The primary alternative hypothesis is that the experimental starategy (coronary stenting with the everolimus-eluting stents) is not inferior to the standard strategy (CABG) or SES.

All consecutive patients with unprotected LMCA diseases at participating centers, who are treated with Xience V stent, will be evaluated for the entry into the study. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01348022
Study type Observational
Source CardioVascular Research Foundation, Korea
Contact
Status Completed
Phase N/A
Start date August 2009
Completion date September 2015

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