Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-01 @ 2:33 AM
Study NCT ID:
NCT03600961
Status:
TERMINATED
Last Update Posted:
2024-02-15
First Post:
2018-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIOFLOW-SV Portugal Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'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': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Problem with enrollment due to Covid-19', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure for the small vessel group', 'timeFrame': 'at 12 months', 'description': 'Primary endpoint will be Target Lesion Failure (TLF) at 12 months for the small vessels group, defined as a composite of cardiac death, target vessel Myocardial Infarction (MI) or clinically driven Target Lesion Revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'TLF for the overall cohort', 'timeFrame': 'at 12 months', 'description': 'TLF at 12 months post procedure for the overall cohort'}, {'measure': 'Clinically driven Target Lesion Revascularization (TLR)', 'timeFrame': 'at 6 and 12 months', 'description': 'Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months post procedure'}, {'measure': 'Clinically driven Target Vessel Revascularization (TVR)', 'timeFrame': 'at 6 and 12 months', 'description': 'Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months post procedure'}, {'measure': 'Definite and probable stent thrombosis', 'timeFrame': 'at 6 and 12 months', 'description': 'Definite and probable stent thrombosis at 6 and 12 months post procedure (ARC Definition)'}, {'measure': 'Procedure success', 'timeFrame': '12 months', 'description': "defined as achievement of a final diameter stenosis of \\<30% by investigator's visual estimate (using any percutaneous method) without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay"}, {'measure': 'Device success', 'timeFrame': '12 months', 'description': "defined as a final residual diameter stenosis of \\<30% by investigator's visual estimate, using the assigned device only, successful delivery of the stent to the target lesion site in the coronary artery, appropriate stent deployment, and successful removal of the device. Post-dilatation is allowed to achieve device success"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm', 'detailedDescription': 'Prospective, single-arm, multi-center, all-comers registry with clinical follow-up visits at the hospital or by phone at 6 and 12 months post-procedure. A minimum of 1000 patients will be enrolled in approximately 15 sites in Brazil, including at least 415 patients with reference vessel diameter ≤2.75 mm as assessed by online QCA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This registry will include subjects requiring a treatment of coronary artery disease with an Orsiro DES', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is ≥18 years of age\n* Subject must sign a Patient Informed Consent (PIC) or a Patient Data Release Form (PDRF)\n* Subject must agree to undergo all required follow-up visits\n\nExclusion Criteria:\n\n* Pregnant and/or breast feeding females at the time of enrolment\n* Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, heparin or any other anticoagulant\n\n /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs, or the stent materials that cannot be adequately pre-medicated\n* Currently participating in another study that has not yet reached the primary endpoint'}, 'identificationModule': {'nctId': 'NCT03600961', 'acronym': 'BIOFLOW-SV', 'briefTitle': 'BIOFLOW-SV Portugal Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik AG'}, 'officialTitle': 'BIOTRONIK - SaFety and Performance Registry for an Allcomers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels - Portugal Registry', 'orgStudyIdInfo': {'id': 'C1704'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Orsiro Sirolimus Eluting Coronary Stent System', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2799-134', 'city': 'Carnaxide', 'country': 'Portugal', 'facility': 'Hospital de Santa Cruz', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}, {'city': 'Carnaxide', 'country': 'Portugal', 'facility': 'Hospital da Luz', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}, {'city': 'Evora', 'country': 'Portugal', 'facility': 'Hospital Espirito Santo Evora', 'geoPoint': {'lat': 38.56587, 'lon': -7.90405}}, {'zip': '2410-197', 'city': 'Leiria', 'country': 'Portugal', 'facility': 'Centro Hospitaler de Leiria E.P.E.', 'geoPoint': {'lat': 39.74362, 'lon': -8.80705}}], 'overallOfficials': [{'name': 'Pedro Braga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Hospitalar de Vila Nova de Gaia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}