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NCT03871127 Clinical Trial

Ten-Year Outcomes of PRE-COMBAT Trial

Coronary Artery Disease Clinical Trial

— PRECOMBAT  

Official title:
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: PRE-COMBAT Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03871127
Other study ID # AMCCV2019-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date February 24, 2020

Study information
Verified date June 2020
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Description:

This study is an extended one of PRECOMBAT trial.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date February 24, 2020
Est. primary completion date February 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject group enrolled in PRECOMBAT trial

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous coronary intervention
Using sirolimus eluting stent
• coronary artery bypass graft
coronary artery bypass graft

Locations
Country Name City State
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Seoul National University Bundang hospital Seongnam
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon
Korea, Republic of Ulsan University Hospital Ulsan

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