Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 3:59 PM
Study NCT ID:
NCT03461367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-08
First Post:
2018-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CTO Registry From Insight of IVUS in Fuwai Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2018-03-03', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target vessel revascularization', 'timeFrame': '5-year follow-up after index PCI', 'description': 'Any ischemic driven revascularization of the target vessel'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': 'Within the first 1 month after PCI and during the 5-year follow-up', 'description': 'Any cause of death'}, {'measure': 'Cardiac death', 'timeFrame': 'Within the first 1 month after PCI and during the 5-year follow-up', 'description': 'Cardiac death'}, {'measure': 'Myocardial infarction', 'timeFrame': 'Within the first 1 month after PCI and during the 5-year follow-up', 'description': 'Any myocardial infarction including perioperative MI'}, {'measure': 'Stroke', 'timeFrame': 'Within the first 1 month after PCI and during the 5-year follow-up', 'description': 'Ischemic or hemorrhagic stroke'}, {'measure': 'Major adverse cardiac and cerebrovascular events (MACCE)', 'timeFrame': 'Within the first 1 month after PCI and during the 5-year follow-up', 'description': 'Including all-cause death, myocardial infarction, stroke or any target vessel revascularization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Heart Disease', 'Chronic Total Occlusion of Coronary Artery', 'Percutaneous Coronary Intervention', 'Intravascular Ultrasound']}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term outcome of chronic total occlusion (CTO) patients underwent contemporary percutaneous coronary intervention (PCI) techniques, we design this single-center, large-sample, prospective registry with five-year clinical follow-up, based on the intravascular ultrasound (IVUS) finding.', 'detailedDescription': 'The study plan to include the patients with a CTO lesion in one of the three main epicardial coronary artery (diameter more than 2.5 mm) as the only target lesion. The CTO lesion is defined as 0 grade of thrombolysis in myocardial infarction (TIMI) flow with evidence of occlusion duration more than 3 months. All the PCI procedure will be performed by a group of certified operators in Fuwai Hospital, Beijing, China. All patients evaluate IVUS with automatic pullback (Opticross, Boston Scientific, US) performed after wire crossing. All the included patients are planned for five-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'CTO Patients who underwent PCI with contemporary CTO techniques by certified operators in Fuwai Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient \\>18 years old\n* Thrombolysis in myocardial infarction trial (TIMI) 0 grade.\n* Evidence of occlusion period more than 3 months.\n* Patients eligible for PCI.\n* Patients eligible for coronary artery bypass graft (CABG).\n* Target vessel is one of the three main epicardial coronary arteries.\n\nExclusion Criteria:\n\n* Acute myocardial infarction with ongoing ST-elevation\n* Target vessel is left main or graft vessel.\n* Target vessel diameter \\< 2.5 mm.\n* Other situations ineligible for PCI judged in clinical practice.\n* Left ventricular ejection fraction \\<30%'}, 'identificationModule': {'nctId': 'NCT03461367', 'acronym': 'FWCTO', 'briefTitle': 'CTO Registry From Insight of IVUS in Fuwai Hospital', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Contemporary Chronic Total Occlusion Percutaneous Coronary Intervention Registry From Insight of Intravascular Ultrasound in Fuwai Hospital', 'orgStudyIdInfo': {'id': '20180223'}}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Lei Song', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Bo Xu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fuwai Hospital, Catheter Lab'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lei Song, MD', 'investigatorAffiliation': 'China National Center for Cardiovascular Diseases'}}}}