Japanese CTO PCI Expert Registry

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Total Occlusion of Coronary Artery

• Study Type: Observational
• Enrollment (Anticipated): 19000

Contacts and Locations

• Study Contact: Name: Keiko Oka; Phone Number: 2742 81-86-422-0210; Email: cto.e.registry@gmail.com
• Study Contact Backup: Name: Harumi Katoh, MD, PhD; Phone Number: 81-86-422-0210; Email: hk10731@kchnet.or.jp

Study Locations

• Japan
  • Kurashiki, Japan, 710-8602
    • Recruiting
    • Kurashiki Central Hospital
    • Contact: Keiko Oka; Phone Number: 81-86-422-0210

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who underwent PCI for CTO lesions by Japanese certified operators

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PCI for CTO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kurashiki Central Hospital
• Collaborators: Japanese CTO PCI Expert Registry investigators

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: June 26, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Estimate): July 2, 2013
• Last Update Submitted That Met QC Criteria: July 1, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: J-CTOPCI-ER2013