Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT03745066
Status:
UNKNOWN
Last Update Posted:
2021-04-26
First Post:
2018-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioFreedom French Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-04-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-23', 'studyFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DOCE', 'timeFrame': '1 year', 'description': 'Device-oriented composite endpoint (DOCE) at 12 months defined as composite of cardiovascular death (CD), myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (cd-TLR).'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '12-month and 24-month', 'description': '1\\. All-cause mortality, CD, non-cardiovascular and undetermined death in hospital and at 12 and 24 months'}, {'measure': 'Patient-oriented composite endpoint (POCE) at 12 and 24 months', 'timeFrame': '12 months and 2 years', 'description': 'Patient-oriented composite endpoint (POCE) at 12 and 24 months defined as all-cause mortality, any stroke, any MI (including nontarget vessel territory) and any revascularization.'}, {'measure': 'Composite of Cardiovascular Death (CD) at 12 and 24 months', 'timeFrame': '12 months and 2 years', 'description': 'Composite of CD, MI and definite/probable stent thrombosis (ST) at 12 and 24 months.'}, {'measure': 'Definite/probable ST at 12 and 24 months', 'timeFrame': '12 months and 24 months', 'description': 'Definite/probable ST at 12 and 24 months'}, {'measure': 'Target Vessel Failure defined at 12 and 24 months', 'timeFrame': '12 months and 24 months', 'description': 'Target Vessel Failure (TVF) defined as CD, target-vessel-related MI, and Target vessel revascularization (TVR) at 12 and 24 months'}, {'measure': 'Target Lesion Failure at 12 and 24 months', 'timeFrame': '12 months and 24 months', 'description': 'Target Lesion Failure (TLF) defined as CD, target-vessel-related MI, and clinically driven TLR at 12 and 24 months'}, {'measure': 'Clinically driven TLR at any follow-up time point', 'timeFrame': 'Inclusion, 12 months and 24 months', 'description': 'Clinically driven TLR at any follow-up time point'}, {'measure': 'Clinically driven TVR at any follow-up time point', 'timeFrame': 'Inclusion, 12 months and 24 months', 'description': 'Clinically driven TVR at any follow-up time point'}, {'measure': 'Any revascularization', 'timeFrame': 'within 24 months following the index procedure', 'description': 'Any revascularization within 24 months following the index procedure, unless they are planned within the 1st month'}, {'measure': 'Stroke, disabling and non-disabling.', 'timeFrame': 'Inclusion, 12 months and 24 months', 'description': 'Stroke, disabling and non-disabling.'}, {'measure': 'BARC 3 to 5 bleeding', 'timeFrame': 'Inclusion, 12 months and 24 months', 'description': 'BARC 3 to 5 bleeding'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.\n\nThe purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.', 'detailedDescription': "Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.\n\nThe registry will be purely observational and will not interfere with physician's decisions relating to stent selection or indication for treatment.\n\nThe purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ DCS within the indications of the Instructions for Use.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with one or more BioFreedom™ DCS .Patients who agree to comply with the follow up requirements. .Patients with a life expectancy of \\> 1 year at time of consent. .Patients eligible to receive dual anti platelet therapy (DAPT).\n* Patients who have signed an Informed Consent\n\nExclusion Criteria:\n\n* Patients unable or unwilling to give documented informed consent\n* Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint .Patient has received an additional stent different from a BioFreedom™ DCS stent during the index procedure.\n* Pregnant or breastfeeding women\n* Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for non HBR patients\n* Planned surgery within 1 month of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for HBR patients\n* Patients under judicial protection, tutorship or curatorship'}, 'identificationModule': {'nctId': 'NCT03745066', 'briefTitle': 'BioFreedom French Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosensors Europe SA'}, 'officialTitle': 'A Post-Market Registry of the BioFreedomTM Biolimus A9TM Coated Coronary Stent System', 'orgStudyIdInfo': {'id': '18-EU-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '63050', 'city': 'Clermont-Ferrand', 'state': 'Cedex 2', 'country': 'France', 'facility': 'Clinique Des Dômes', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '91480', 'city': 'Quincy-sous-Sénart', 'state': 'Essonne', 'country': 'France', 'facility': 'at Hôpital Privé Claude Galien ICPS', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}, {'zip': '21121', 'city': 'Fontaine-lès-Dijon', 'country': 'France', 'facility': 'Clinique de Fontaine', 'geoPoint': {'lat': 47.34238, 'lon': 5.02007}}, {'zip': '67504', 'city': 'Haguenau', 'country': 'France', 'facility': 'Centre Hospitalier General', 'geoPoint': {'lat': 48.81557, 'lon': 7.79051}}, {'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'Clinique Saint Martin', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse Rangeuil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Janusz Lipiecki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique des Dômes'}, {'name': 'Philippe Garot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICPS, Massy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosensors Europe SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'European Cardiovascular Research Center', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}