Clinical trial NCT04041921: Chronic Total Occlusion Registry
Official title: A Multicenter, Prospective, Real World Observational Study for Chronic Total Occlusion
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Occlusion
Coronary Artery Stenosis
Coronary Stenosis
Keywords: CTO
PCI
CABG
Medical treatment
Decision CTO
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2019-08-01
Enrollment: 4006
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite event of all cause death, myocardial infarction, stroke or all kinds of repeat revascularization
timeFrame: 10 years
Secondary outcomes:
measure: Event rate of all cause death
timeFrame: 10 years
measure: Event rate of acute myocardial infarction
timeFrame: 10 years
measure: Event rate of stroke
timeFrame: 10 years
measure: Event rate of repeat revascularization
timeFrame: 10 years
measure: Event rate of rehospitalization due to acute coronary syndrome
timeFrame: 10 years
measure: The rate change of left ventricular ejection fraction
timeFrame: 10 years
measure: Composite event of death, myocardial, stroke or repeat revascularization
timeFrame: 5 years
measure: Composite event of death, myocardial, stroke or repeat revascularization
timeFrame: 10 years
measure: Event rate of Procedural success
timeFrame: 5 days
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: SAM hospital
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Jeonju
country: Korea, Republic of
facility: ChonBuk National University Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
References: