Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization

Recruiting

• Conditions: Coronary Stenosis; Coronary Artery Bypass Grafting; Coronary Artery Disease Progression; Percutaneous Coronary Revascularization
• Interventions: Procedure: Hybrid Coronary Revascularization

• Registration Number: NCT03788369
• Lead Sponsor: Seung-Jung Park

Brief Summary

This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in real-world practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-25
• Study First Posted: 2018-12-27
• Study Start: 2019-04-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2030-06
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 20 and more
• Hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)
• Written consent

Exclusion Criteria

• Previous CABG(coronary artery bypass graft)
• Life expectancy ≤1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multivessel coronary artery disease	Hybrid Coronary Revascularization	must include left anterior descending artery

Primary Outcome Measures

Name	Time	Method
a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.	5 years	Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.

Secondary Outcome Measures

Name	Time	Method
All death	5 years
Stent thrombosis	5 years	by an Academic Research Consortium (ARC) category
Procedural success	5 days	Procedural success is defined as \< 30% final stenosis and the absence of in-hospital event including death, Q-wave myocardial infarction or urgent repeat revascularization.
a composite event of cardiac death or myocardial infarction	5 years
TVR(Target Vessel Revascularization)	5 years
TLR(Target Lesion Revascularization)	5 years
Cardiac death	5 years
Myocardial infarction	5 years
a composite event of all death or myocardial infarction	5 years
Cerebrovascular event	5 years

Trial Locations

Locations (1)

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