Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT05292118
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2022-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Navitian PMCF Study ( rEPIC04C )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'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': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Endpoint. Freedom fromTarget Lesion Failure', 'timeFrame': '7 days', 'description': 'Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Efficacy Endpoint. Freedom from Target Lesion Failure', 'timeFrame': '7 days', 'description': 'Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).'}, {'measure': 'Freedom from Device rupture', 'timeFrame': 'During percutaneous coronary intervention (PCI)', 'description': 'Freedom from Device rupture'}, {'measure': 'Freedom from Kinking', 'timeFrame': 'During PCI', 'description': 'Freedom from Kinking'}, {'measure': 'Freedom from Complicated withdrawal', 'timeFrame': 'During PCI', 'description': 'Freedom from Complicated withdrawal'}, {'measure': 'Freedom from Coronary perforation', 'timeFrame': 'During PCI', 'description': 'Freedom from Coronary perforation'}, {'measure': 'Freedom from Coronary dissection >C', 'timeFrame': 'During PCI', 'description': 'Freedom from Coronary dissection \\>C'}, {'measure': 'Freedom from No reflow', 'timeFrame': 'During PCI', 'description': 'Freedom from No reflow'}, {'measure': 'Freedom from Coronary thrombosis', 'timeFrame': 'During PCI', 'description': 'Freedom from Coronary thrombosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDR (Medical Device Regulations)', 'PMCF (Post-Market Clinical Follow-up)', 'Coronary microcatheter'], 'conditions': ['Coronary Artery Disease (CAD)', 'Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '74678', 'type': 'BACKGROUND', 'citation': 'Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available.'}, {'pmid': '22823494', 'type': 'BACKGROUND', 'citation': 'Obata JE, Nakamura T, Kitta Y, Saito Y, Sano K, Fujioka D, Kawabata K, Kugiyama K. Usefulness of a collateral channel dilator for antegrade treatment of chronic total occlusion of a coronary artery. J Interv Cardiol. 2012 Dec;25(6):533-9. doi: 10.1111/j.1540-8183.2012.00758.x. Epub 2012 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Navitian to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Navitian.', 'detailedDescription': 'The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Navitian in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Navitian according to routine hospital practice and following instructions for use', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient treated with Navitian according to routine hospital practice and following instructions for use\n* Informed consent signed\n\nExclusion Criteria:\n\n* Not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05292118', 'acronym': 'rEPIC04C', 'briefTitle': 'Navitian PMCF Study ( rEPIC04C )', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'Navitian Post-Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'Navitian PMCF Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Disease (CAD)', 'interventionNames': ['Device: Navitian']}], 'interventions': [{'name': 'Navitian', 'type': 'DEVICE', 'description': 'Patients in whom treatment with (Navitian) has been attempted', 'armGroupLabels': ['Coronary Artery Disease (CAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4434-502', 'city': 'Vila Nova de Gaia', 'country': 'Portugal', 'facility': 'Centro Hospitalar Vila Nova de Gaia', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '21005', 'city': 'Huelva', 'country': 'Spain', 'facility': 'Hospital Universitario Juan Ramon Jimenez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '24071', 'city': 'León', 'country': 'Spain', 'facility': 'Hospital Universitario de Leon', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '27003', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Hospital Universitario Lucus Agusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}