IRIS CTO: Chronic Total Occlusion Registry

Sponsor

Seung-Jung Park (Other)

Overall Status

Terminated

CT.gov ID

NCT04041921

Collaborator

CardioVascular Research Foundation, Korea (Other)

4,006

Enrollment

Locations

147.2

Actual Duration (Months)

210.8

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluated the long-term outcome of patients with chronic total occlusion treated with percutaneous coronary intervention, medical treatment or coronary artery bypass grafting.

Condition or Disease	Intervention/Treatment	Phase
Coronary Occlusion Coronary Artery Stenosis Coronary Stenosis	Procedure: Percutaneous coronary intervention Procedure: Coronary Artery Bypass Grafting Drug: Medical treatment

Detailed Description

This study is connected with Decision-CTO trial(NCT01078051). Randomized subjects and registry group subjects from Decision-CTO trial continue 10 years follow-up on this study.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

4006 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multicenter, Prospective, Real World Observational Study for Chronic Total Occlusion

Actual Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Apr 8, 2022

Actual Study Completion Date :

Apr 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Chronic coronary occlusion patients ≥3 months chronic total occlusion on coronary angiography	Procedure: Percutaneous coronary intervention Procedure: Coronary Artery Bypass Grafting Drug: Medical treatment

Arm

Intervention/Treatment

Chronic coronary occlusion patients

≥3 months chronic total occlusion on coronary angiography

Procedure: Percutaneous coronary intervention

Procedure: Coronary Artery Bypass Grafting

Drug: Medical treatment

Outcome Measures

Primary Outcome Measures

Composite event of all cause death, myocardial infarction, stroke or all kinds of repeat revascularization [10 years]

Secondary Outcome Measures

Event rate of all cause death [10 years]
Event rate of acute myocardial infarction [10 years]
Event rate of stroke [10 years]
Event rate of repeat revascularization [10 years]
Event rate of rehospitalization due to acute coronary syndrome [10 years]
The rate change of left ventricular ejection fraction [10 years]
Composite event of death, myocardial, stroke or repeat revascularization [5 years]
Composite event of death, myocardial, stroke or repeat revascularization [10 years]
Event rate of 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with angina or silent ischemia and documented ischemia
Patients with De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography
Age > 18 years

Exclusion Criteria:

Refuse to participate in this study

Contacts and Locations

Locations

	Site	City	Country
1	SAM hospital	Anyang	Korea, Republic of
2	Soon Chun Hyang University Hospital Bucheon	Bucheon	Korea, Republic of
3	Soon Chun Hyang University Hospital Cheonan	Cheonan	Korea, Republic of
4	Chungbuk National University Hospital	Cheongju	Korea, Republic of
5	Gangwon National Univ. Hospital	Chuncheon	Korea, Republic of
6	Keimyung University Dongsan Medical Center	Daegu	Korea, Republic of
7	Chungnam National University Hospital	Daejeon	Korea, Republic of
8	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon	Korea, Republic of
9	Gangneung Asan Hospital	Gangneung	Korea, Republic of
10	Chonnam National University Hospital	Gwangju	Korea, Republic of
11	ChonBuk National University Hospital	Jeonju	Korea, Republic of
12	Dong-A Medical Center	Pusan	Korea, Republic of
13	Pusan National University Yangsan Hospital	Pusan	Korea, Republic of
14	Bundang CHA Hospital	Seongnam	Korea, Republic of
15	Asan Medical Hospital	Seoul	Korea, Republic of
16	Korea University Guro Hospital	Seoul	Korea, Republic of
17	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul	Korea, Republic of
18	Ulsan University Hospital	Ulsan	Korea, Republic of
19	Wonju Severance Christian Hospital	Wonju	Korea, Republic of