Chronic Total Occlusion Registry (IRIS CTO)

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Occlusion; Coronary Stenosis; Coronary Artery Stenosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 4006

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite event of all cause death, myocardial infarction, stroke or all kinds of repeat revascularization	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): April 8, 2022
• Study Completion (Actual): April 8, 2022

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: PCI; CABG; CTO; Medical treatment; Decision CTO
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease; Constriction, Pathologic; Coronary Occlusion; Coronary Stenosis
• Other Study ID Numbers: CVRF2009-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No