NCT01889459

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
19,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress89%
Jul 2013Dec 2027

First Submitted

Initial submission to the registry

June 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

9.4 years

First QC Date

June 26, 2013

Last Update Submit

July 1, 2013

Conditions

Chronic Total Occlusion of Coronary Artery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

PCI for CTO

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent PCI for CTO lesions by Japanese certified operators

You may qualify if:

  • Patients eligible for PCI
  • Patients who underwent PCI for CTO lesions that contain the following:
  • Thrombolysis in myocardial infarction trial (TIMI) 0
  • The occlusive period more than 3 months or unknown
  • The main coronary arteries (segment 1-3, 5-8, 11, 13), branches that have large perfusion area (segment 4PL, 9/10, 12) and graft

You may not qualify if:

  • Patients ineligible for PCI judged in clinical practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kurashiki Central Hospital

Kurashiki, 710-8602, Japan

RECRUITING

Central Study Contacts

Keiko Oka

CONTACT

81-86-422-0210cto.e.registry@gmail.com

Harumi Katoh, MD, PhD

CONTACT

81-86-422-0210hk10731@kchnet.or.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

June 28, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2022

Study Completion (Estimated)

December 1, 2027

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

JP(1)