Chronic Total Occlusion of Coronary ArteryNCT01889459
Japanese CTO PCI Expert Registry
An observational study of Chronic Total Occlusion of Coronary Artery, run by Kurashiki Central Hospital at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- How many people
- 19,000 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2013to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent PCI for CTO lesions by Japanese certified operators
Who may be able to join
- 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
Who cannot join
- Patients ineligible for PCI judged in clinical practice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Kurashiki Central Hospital
Kurashiki, 710-8602
Keiko Oka, 81-86-422-0210
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCI for CTO | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within the first 1 month (plus 1 month) after PCI and during the 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2022 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kurashiki Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Japanese CTO PCI Expert Registry investigators
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889459
- Sponsor's protocol ID
- J-CTOPCI-ER2013
- Status last verified
- Jul 2013
- First submitted
- 26 Jun 2013
- Last updated
- 2 Jul 2013
- Results posted
- No
Publications
Tanaka H, Tsuchikane E, Kishi K, Okada H, Oikawa Y, Ito Y, Muramatsu T, Yoshikawa R, Kawasaki T, Okamura A, Sumitsuji S, Muto M, Katoh O. Retrograde Coronary Chronic Total Occlusion Intervention (JR-CTO) Score: From the Japanese CTO-PCI Expert Registry. JACC Cardiovasc Interv. 2024 Jun 10;17(11):1374-1384. doi: 10.1016/j.jcin.2024.03.023. Epub 2024 May 1.
PubMed 38703149
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Registry of Percutaneous Coronary Intervention (PCI) for Chronic Total Occlusion (CTO) by Japanese Experts
- ClinicalTrials.gov ID
- NCT01889459
- Acronym / sponsor ID
- J-CTOPCI-ER2013
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 19,000 participants (estimated)
- Lead sponsor
- Kurashiki Central HospitalUniversity, hospital or other
- Collaborators
- Japanese CTO PCI Expert Registry investigators
- Study start
- Jul 2013
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI for CTO | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent PCI for CTO lesions by Japanese certified operators
Key inclusion criteria (5 listed)
- Patients eligible for PCI
- 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
Key exclusion criteria (1 listed)
- Patients ineligible for PCI judged in clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
successful revascularization without any major adverse cardiocerebral events (MACCE) at early follow-up and MACCE during the 5-year follow-up
Time frame: within the first 1 month (plus 1 month) after PCI and 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
- Derived from this study: PubMed 38703149Tanaka H, Tsuchikane E, Kishi K, Okada H, Oikawa Y, Ito Y, Muramatsu T, Yoshikawa R, Kawasaki T, Okamura A, Sumitsuji S, Muto M, Katoh O. Retrograde Coronary Chronic Total Occlusion Intervention (JR-CTO) Score: From the Japanese CTO-PCI Expert Registry. JACC Cardiovasc Interv. 2024 Jun 10;17(11):1374-1384. doi: 10.1016/j.jcin.2024.03.023. Epub 2024 May 1.
Related trials for Chronic Total Occlusion of Coronary Artery
Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
Chronic Total Occlusion of Coronary Artery
RecruitingObservational study
Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
RecruitingObservational study
TRIO CTO (Taiwan Research Initiative on Coronary Total Occlusion)
Chronic Total Occlusion (CTO)
Not yet recruiting
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Angina (Stable), Coronary Occlusion
RecruitingObservational study
Risk Factors and Outcomes in Coronary Chronic Total Occlusion
Chronic Total Occlusion, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Occlusion of Coronary Artery, run by Kurashiki Central Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keiko Oka (81-86-422-0210 ext. 2742, cto.e.registry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful revascularization without any major adverse cardiocerebral events (MACCE) at early follow-up and MACCE during the 5-year follow-up (time frame: within the first 1 month (plus 1 month) after PCI and during the 5-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01889459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013; AzTrials last refreshed its copy on 31 Oct 2026.