Chronic Total Occlusion Registry

Coronary Stenosis Clinical Trial

— IRIS CTO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04041921
• Other study ID #: CVRF2009-06
• Status: Terminated
• Start date: January 2010
• Est. completion date: April 8, 2022

Study information

• Verified date: April 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4006
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Stenosis
• Coronary Occlusion
• Coronary Stenosis

Intervention

Procedure:
• Percutaneous coronary intervention

• Coronary Artery Bypass Grafting

Drug:
• Medical treatment

Locations

Country	Name	City	State
Korea, Republic of	SAM hospital	Anyang
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	ChonBuk National University Hospital	Jeonju
Korea, Republic of	Dong-A Medical Center	Pusan
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	Asan Medical Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

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