Japanese CTO PCI Expert Registry

Chronic Total Occlusion of Coronary Artery Clinical Trial

Official title:

Patient Registry of Percutaneous Coronary Intervention (PCI) for Chronic Total Occlusion (CTO) by Japanese Experts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01889459
• Other study ID #: J-CTOPCI-ER2013
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2013
• Last updated: July 1, 2013
• Start date: July 2013
• Est. completion date: December 2027

Study information

• Verified date: July 2013
• Source: Kurashiki Central Hospital
• Contact: Keiko Oka
• Phone: 81-86-422-0210
• Email: cto.e.registry[@]gmail.com
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to establish a consensus of treatment strategy of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) through patient registry of PCI for CTO performed by Japanese certified operators.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19000
• Est. completion date: December 2027
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

Patients eligible for PCI

Patients who underwent PCI for CTO lesions that contain the following:

1. Thrombolysis in myocardial infarction trial (TIMI) 0

2. The occlusive period more than 3 months or unknown

3. The main coronary arteries (segment 1-3, 5-8, 11, 13), branches that have large perfusion area (segment 4PL, 9/10, 12) and graft

Exclusion Criteria:

Patients ineligible for PCI judged in clinical practice

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery

Locations

Country	Name	City	State
Japan	Kurashiki Central Hospital	Kurashiki

Sponsors (2)

Lead Sponsor	Collaborator
Kurashiki Central Hospital	Japanese CTO PCI Expert Registry investigators

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful revascularization without any major adverse cardiocerebral events (MACCE) at early follow-up and MACCE during the 5-year follow-up	early and late results on major adverse cardiocerebral events (MACCE): all-cause death, coronary artery bypass grafting, re-PCI (target lesion revascularization/target vessel revascularization), admission for heart failure, myocardial infarction, admission for unstable angina, cerebrovascular disease, stent thrombosis in 19000 patients in and outside Japan	within the first 1 month (plus 1 month) after PCI and during the 5-year follow-up	Yes