Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-03-17 @ 11:57 AM
Study NCT ID:
NCT01889459
Status:
RECRUITING
Last Update Posted:
2013-07-02
First Post:
2013-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese CTO PCI Expert Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-01', 'studyFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'successful revascularization without any major adverse cardiocerebral events (MACCE) at early follow-up and MACCE during the 5-year follow-up', 'timeFrame': 'within the first 1 month (plus 1 month) after PCI and during the 5-year follow-up', 'description': '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'}]}, 'conditionsModule': {'conditions': ['Chronic Total Occlusion of Coronary Artery']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent PCI for CTO lesions by Japanese certified operators', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients eligible for PCI\n\nPatients who underwent PCI for CTO lesions that contain the following:\n\n1. Thrombolysis in myocardial infarction trial (TIMI) 0\n2. The occlusive period more than 3 months or unknown\n3. The main coronary arteries (segment 1-3, 5-8, 11, 13), branches that have large perfusion area (segment 4PL, 9/10, 12) and graft\n\nExclusion Criteria:\n\nPatients ineligible for PCI judged in clinical practice'}, 'identificationModule': {'nctId': 'NCT01889459', 'briefTitle': 'Japanese CTO PCI Expert Registry', 'organization': {'class': 'OTHER', 'fullName': 'Kurashiki Central Hospital'}, 'officialTitle': 'Patient Registry of Percutaneous Coronary Intervention (PCI) for Chronic Total Occlusion (CTO) by Japanese Experts', 'orgStudyIdInfo': {'id': 'J-CTOPCI-ER2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCI for CTO'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710-8602', 'city': 'Kurashiki', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Keiko Oka', 'role': 'CONTACT', 'phone': '81-86-422-0210'}], 'facility': 'Kurashiki Central Hospital', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}], 'centralContacts': [{'name': 'Keiko Oka', 'role': 'CONTACT', 'email': 'cto.e.registry@gmail.com', 'phone': '81-86-422-0210', 'phoneExt': '2742'}, {'name': 'Harumi Katoh, MD, PhD', 'role': 'CONTACT', 'email': 'hk10731@kchnet.or.jp', 'phone': '81-86-422-0210'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kurashiki Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Japanese CTO PCI Expert Registry investigators', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}