Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT04234893
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2020-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bingo Drug-Coated Balloon in Real World
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 805}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-26', 'studyFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events', 'timeFrame': '12 months', 'description': 'a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'device success', 'timeFrame': 'immediately after the procedure', 'description': 'study device successfully dilate in the lesion without using bail-out stent'}, {'measure': 'lesion success', 'timeFrame': 'immediately after the procedure', 'description': 'residual diameter stenosis ≤30% and the TIMI flow grade 3 of the target lesion'}, {'measure': 'clinical success', 'timeFrame': 'immediately after the procedure， up to 7 days', 'description': 'lesion success without in-hospital MACE'}, {'measure': 'rate of Target lesion revascularization', 'timeFrame': '1, 6, 12 and 24 months', 'description': 'repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion'}, {'measure': 'Target lesion failure', 'timeFrame': '1, 6, 12 and 24 months', 'description': 'a composite endpoint of cardiovascular death, target vessel myocardial infarction, clinical driven target lesion revascularization'}, {'measure': 'Acute vessel closure', 'timeFrame': 'during the procedure and up to 24 hours'}, {'measure': 'Target lesion thrombosis', 'timeFrame': 'immediately after the procedure， up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Stenosis', 'Percutaneous Coronary Intervention', 'Drug-coated Balloon', 'Drug eluting Balloon', 'Paclitaxel', 'De novo', 'Bifurcation', 'Coronary Artery Disease'], 'conditions': ['Coronary Stenosis', 'Drug-coated Balloon', 'De Novo Stenosis', 'Coronary Artery Disease in Transplanted Heart Accelerated']}, 'descriptionModule': {'briefSummary': 'The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'PCI with Bingo drug-coated balloon', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or older, regardless of gender;\n2. Patients suitable for PCI with paclitaxel drug-coated balloon;\n3. Patients able to understand the purpose of this study, provide an informed consent and cooperate with clinical follow-up.\n\nExclusion Criteria:\n\nGeneral exclusion criteria\n\n1. Contraindications to PCI;\n2. In-stent restenosis;\n3. Life expectation less than 1 year;\n4. Patients not suitable for enrollment considered by investigator.\n\nAngiographic exclusion criteria:\n\n1\\. Target lesion with the following conditions after pre-dilatation:\n\n1. Residual stenosis larger than 30% ;\n2. TIMI flow grade less than 3;\n3. Type C-F dissection (NHLBI grade).'}, 'identificationModule': {'nctId': 'NCT04234893', 'briefTitle': 'Bingo Drug-Coated Balloon in Real World', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yinyi(Liaoning) Biotech Co., Ltd.'}, 'officialTitle': 'A Registry Study of Bingo Drug-Coated Balloon in Real World', 'orgStudyIdInfo': {'id': 'BEYOND Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Drug-coated balloon', 'description': 'The Patients who treated with Bingo drug-coated balloon'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Jian-an Wang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yinyi(Liaoning) Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}