CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,454 enrolled
Drug / intervention
Percutaneous coronary intervention +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00422968
NCT00422968Phase 3Completed
CompareCT.gov

PREmier of Randomized COMparison of Bypass Surgery Versus AngioplasTy Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease

Seung-Jung Park·interventional·Posted Jan 17, 2007·Updated May 1, 2014

In Brief

A Phase 3 clinical trial evaluating Percutaneous coronary intervention and coronary artery bypass graft for Coronary Artery Disease. Completed, enrolled 1,454 participants across 13 sites.

Detailed Summary

The primary objective of the PRE-COMBAT trial is: To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting balloon expandable stent (Cordis Johnson \& Johnson, Warren, New Jersey) compared with bypass surgery for the treatment of an unprotected LMCA stenosis. The alternative hypothesis is that the experimental strategy (coronary stenting with the sirolimus-eluting stents) is not inferior to the standard strategy (bypass surgery).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2007
Enrollment StartMar 1, 2005
Primary CompletionNov 1, 2009
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 19.5 years ago

Interventions

Percutaneous coronary interventiondevice

Using silorimus eluting stent

coronary artery bypass graftprocedure

coronary artery bypass graft