Ten-Year Outcomes of PRE-COMBAT Trial

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Percutaneous coronary intervention; Procedure: coronary artery bypass graft

• Registration Number: NCT03871127
• Lead Sponsor: Seung-Jung Park

Brief Summary

This study evaluates Ten-Year Outcomes of PREmier of Randomized Comparison of Sirolimus-Eluting Stent Implantation Versus Coronary Artery Bypass Surgery for Unprotected Left Main Coronary Artery Stenosis(PRECOMBAT trial).

Detailed Description

This study is an extended one of PRECOMBAT trial.

Study Timeline

• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-10
• Study First Posted: 2019-03-12
• Study Start: 2019-05-01
• Primary Completion: 2020-02-24
• Study Completion: 2020-02-24
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Subject group enrolled in PRECOMBAT trial

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Left main coronary disease	Percutaneous coronary intervention	-
Left main coronary disease	coronary artery bypass graft	-

Primary Outcome Measures

Name	Time	Method
Composite outcome	10 year	The composite of death, myocardial infarction, and revascularization. Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, and revascularization

Secondary Outcome Measures

Name	Time	Method
Graft reocclusion rate	10 year
Graft patency rate	10 year
Binary restenosis in both in-stent and in-segment	10 year
All-cause mortality	10 year
Cardiac death	10 year
Cerebrovascular accident	10 year
Target vessel revascularization	10 year
Myocardial infarction	10 year
Stent thrombosis	10 year
Target lesion revascularization	10 year

Trial Locations

Locations (9)

Seoul National University Bundang hospital; 🇰🇷 Seongnam, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of