Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-07 @ 7:30 AM
Study NCT ID:
NCT03229993
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2017-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OCT in Borderline Coronary Artery Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2017-07-23', 'studyFirstSubmitQcDate': '2017-07-23', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACEs', 'timeFrame': '12 months', 'description': 'The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis.'}, {'measure': 'TLR', 'timeFrame': '12 months', 'description': 'The incidence of target lesion revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'Rehospitalization', 'timeFrame': '12 months', 'description': 'The incidence of rehospitalization due to cardiac events'}, {'measure': 'Recurrent angina', 'timeFrame': '12 months', 'description': 'The incidence of recurrent angina'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Optical Coherence Tomography (OCT)', 'Percutaneous Coronary Intervention (PCI)', 'Single-Photon Emission Computed Tomography (SPECT)', 'Coronary Angiography (CAG)', 'Borderline Coronary Artery Lesions']}, 'descriptionModule': {'briefSummary': 'To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis.\n\nIt is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT\'s in the borderline coronary artery stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT.\n\nExclusion Criteria:\n\n* Exclusion criteria will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions.'}, 'identificationModule': {'nctId': 'NCT03229993', 'briefTitle': 'OCT in Borderline Coronary Artery Lesions', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'The Safety and Efficacy of OCT in the Evaluation and Treatment of Angiographically Borderline Coronary Artery Lesions', 'orgStudyIdInfo': {'id': 'OCT-20170723'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCT guided PCI', 'interventionNames': ['Diagnostic Test: OCT']}, {'type': 'EXPERIMENTAL', 'label': 'OCT guided medicine', 'interventionNames': ['Diagnostic Test: OCT']}, {'type': 'NO_INTERVENTION', 'label': 'SPECT guided PCI'}, {'type': 'NO_INTERVENTION', 'label': 'SPECT guided medicine'}], 'interventions': [{'name': 'OCT', 'type': 'DIAGNOSTIC_TEST', 'description': 'OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions', 'armGroupLabels': ['OCT guided PCI', 'OCT guided medicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}