Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization

Coronary Stenosis Clinical Trial

— HCR registry  

Official title:

Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization, a Non-randomized, Prospective, Open-label Registry in Real-world Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788369
• Other study ID #: AMCCV2018-12
• Status: Recruiting
• Start date: April 5, 2019
• Est. completion date: December 2030

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Do-yoon Kang, MD
• Phone: 82-2-3010-1745
• Email: kdy1218[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2030
• Est. primary completion date: June 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Coronary Artery Disease Progression
• Coronary Stenosis
• Disease Progression
• Percutaneous Coronary Revascularization

Intervention

Procedure:
• Hybrid Coronary Revascularization
Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.	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.	5 years
Secondary	All death		5 years
Secondary	Cardiac death		5 years
Secondary	Myocardial infarction		5 years
Secondary	a composite event of all death or myocardial infarction		5 years
Secondary	a composite event of cardiac death or myocardial infarction		5 years
Secondary	TVR(Target Vessel Revascularization)		5 years
Secondary	TLR(Target Lesion Revascularization)		5 years
Secondary	Stent thrombosis	by an Academic Research Consortium (ARC) category	5 years
Secondary	Cerebrovascular event		5 years
Secondary	Procedural success	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.	5 days