Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 2:03 PM
Study NCT ID:
NCT05706805
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NAVISCORE PMCF Study ( rEPIC04F )
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': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Endpoint. Freedom from Target Lesion Failure', 'timeFrame': '7 days', 'description': 'Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)', '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 Balloon rupture', 'timeFrame': 'During PCI (Percutaneous Coronary Intervention)', 'description': 'Freedom from Balloon rupture'}, {'measure': 'Freedom from Hypotube rupture', 'timeFrame': 'During PCI (Percutaneous Coronary Intervention)', 'description': 'Freedom from Hypotube rupture ( partial or total fracture of the shaft of the device)'}, {'measure': 'Freedom from Complicated withdrawal', 'timeFrame': 'During PCI (Percutaneous Coronary Intervention)', 'description': 'Freedom from Complicated withdrawal (difficult or impossible device retrieval that may or may not cause clinical complications)'}, {'measure': 'Freedom from Coronary perforation', 'timeFrame': 'During PCI (Percutaneous Coronary Intervention)', 'description': 'Freedom from Coronary perforation according to the modified Ellis classification'}, {'measure': 'Freedom from Coronary dissection >C', 'timeFrame': 'During PCI (Percutaneous Coronary Intervention)', 'description': 'Freedom from Coronary dissection \\>C according to the NHLBI Classification (National Heart, Lung, and Blood Institute)'}, {'measure': 'Freedom from No reflow', 'timeFrame': 'During PCI (Percutaneous Coronary Intervention)', 'description': 'Freedom from No reflow (persistently slowed flow with residual stenosis \\<30% and no flow-limiting dissection)'}, {'measure': 'Freedom from Coronary thrombosis', 'timeFrame': 'During PCI (Percutaneous Coronary Intervention)', 'description': 'Freedom from Coronary thrombosis according to ARC-2 ( Academic Research Consortium-2) criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDR (Medical Device Regulations)', 'PMCF (Post-Market Clinical Follow-up)', 'Coronary balloon dilatation catheter'], 'conditions': ['Coronary Artery Disease', 'Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '18174614', 'type': 'BACKGROUND', 'citation': 'Fonseca A, Costa Jde R Jr, Abizaid A, Feres F, Abizaid AS, Costa R, Staico R, Mattos LA, Sousa AG, Grube E, Sousa JE. Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions. J Invasive Cardiol. 2008 Jan;20(1):21-7.'}, {'pmid': '22927100', 'type': 'BACKGROUND', 'citation': "Weisz G, Metzger DC, Liberman HA, O'Shaughnessy CD, Douglas JS Jr, Turco MA, Mehran R, Gershony G, Leon MB, Moses JW. A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch: final results of the AGILITY trial. Catheter Cardiovasc Interv. 2013 Sep 1;82(3):352-9. doi: 10.1002/ccd.24630. Epub 2013 Mar 9."}, {'type': 'BACKGROUND', 'citation': 'US FDA: Summary of Safety and Effectiveness Data (SSED): AngioSculpt®Scoring Balloon Catheter (2007) www.accessdata.fda.gov/cdrh_docs/pdf5/P050018b.pdf'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.', '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 Naviscore scoring balloon 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 Naviscore according to routine hospital practice and following instructions for use', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient treated with Naviscore 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': 'NCT05706805', 'acronym': 'rEPIC04F', 'briefTitle': 'NAVISCORE PMCF Study ( rEPIC04F )', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'NAVISCORE Post-Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'NAVISCORE PMCF Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Disease (CAD)', 'interventionNames': ['Device: Naviscore']}], 'interventions': [{'name': 'Naviscore', 'type': 'DEVICE', 'description': 'Patients in whom treatment with (Naviscore) has been attempted', 'armGroupLabels': ['Coronary Artery Disease (CAD)']}]}, 'contactsLocationsModule': {'locations': [{'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': '10003', 'city': 'Cáceres', 'country': 'Spain', 'facility': 'Hospital Universitario de Cáceres', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '21005', 'city': 'Huelva', 'country': 'Spain', 'facility': 'Hospital Universitario Juan Ramon Jimenez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '24008', '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': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}