NCT04041921

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,006

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

12.3 years

First QC Date

July 25, 2019

Last Update Submit

April 11, 2022

Conditions

Coronary OcclusionCoronary Artery StenosisCoronary Stenosis

Keywords

CTOPCICABGMedical treatmentDecision CTO

Outcome Measures

Primary Outcomes (1)

  • Composite event of all cause death, myocardial infarction, stroke or all kinds of repeat revascularization

    10 years

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Chronic coronary occlusion patients

≥3 months chronic total occlusion on coronary angiography

Procedure: Percutaneous coronary interventionProcedure: Coronary Artery Bypass GraftingDrug: Medical treatment

Interventions

Percutaneous coronary interventionPROCEDURE
Chronic coronary occlusion patients
Coronary Artery Bypass GraftingPROCEDURE
Chronic coronary occlusion patients
Medical treatmentDRUG
Chronic coronary occlusion patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Refuse to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

SAM hospital

Anyang, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

ChonBuk National University Hospital

Jeonju, South Korea

Location

Dong-A Medical Center

Pusan, South Korea

Location

Pusan National University Yangsan Hospital

Pusan, South Korea

Location

Bundang CHA Hospital

Seongnam, South Korea

Location

Asan Medical Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Coronary OcclusionCoronary Stenosis

Interventions

Percutaneous Coronary InterventionCoronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresMyocardial RevascularizationCardiac Surgical ProceduresVascular GraftingThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor,University of Ulsan College of Medicine

Study Record Dates

First Submitted

July 25, 2019

First Posted

August 1, 2019

Study Start

January 1, 2010

Primary Completion

April 8, 2022

Study Completion

April 8, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Locations

KR(19)