Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06446102
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bifurcation Coronary Lesion 0-0-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-16', 'size': 397342, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-17T16:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 273}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events', 'timeFrame': '3 years', 'description': 'Composite of cardiovascular death rate, myocardial infarction rate and target vessel revascularization rate.'}], 'secondaryOutcomes': [{'measure': 'Target lesion revascularization', 'timeFrame': '3 years', 'description': 'Target lesion revascularization rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Bifurcation Stenosis']}, 'descriptionModule': {'briefSummary': 'Research Involving Human Persons (RIHP 3) focusing on the treatment of type 0-0-1 bifurcation lesions in routine practice. Multicenter Study.\n\nTo retrieve and analyze the details of different angioplasty techniques used in this type of bifurcation lesion (Medina 0-0-1) in order to describe current practice and search for predictors of clinical events.', 'detailedDescription': 'The primary objective of the trial is to estimate the frequency of Major Adverse Cardiac Events (MACE), including cardiac death, myocardial infarction within the territory of the treated lesion, and revascularization of the target lesion in a representative population of patients treated by coronary angioplasty of type 0-0-1 bifurcation lesions.\n\nThe sample size will be determined by the number of angioplasties of type 0-0-1 bifurcation lesions performed at each center between 2016 and 2022.\n\nSince the trial is observational in nature and there are no previously published studies, the sample size cannot be calculated based on the desired precision of the estimation.\n\nFurthermore, the purpose of the study is also to assess the techniques used to treat this type of coronary bifurcation and to highlight any differences between different centers and with other types of coronary bifurcation lesions described in the literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In this trial, approximately 300 patients will be recruited from the Hôpital Privé Jacques Cartier in Massy, Clinique Pasteur in Toulouse, and Maasstad Hospital in Rotterdam between 2016 and 2022.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 years and older,\n* Who underwent angioplasty for a coronary bifurcation lesion of type 0-0-1 between 2016 and 2022.\n\nExclusion Criteria:\n\n\\- Opposing the collection and processing of necessary data and refusing additional telephone follow-up'}, 'identificationModule': {'nctId': 'NCT06446102', 'briefTitle': 'Bifurcation Coronary Lesion 0-0-1', 'organization': {'class': 'OTHER', 'fullName': 'RCF@ICPS'}, 'officialTitle': 'Bifurcation Coronary Lesion 0-0-1', 'orgStudyIdInfo': {'id': '23.02718.000229'}}, 'contactsLocationsModule': {'locations': [{'zip': '91300', 'city': 'Massy', 'country': 'France', 'facility': 'Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '3079 DZ', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Maasstad Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Francesca SANGUINETI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICPS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RCF@ICPS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francesca SANGUINETI', 'investigatorAffiliation': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}}}}