Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT04598802
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2020-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COvera in BRAnch Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'technical success', 'timeFrame': '30 days', 'description': 'freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking'}, {'measure': 'Branch instability', 'timeFrame': '30 days', 'description': 'freedom from branch-related complications'}, {'measure': 'Primary clinical success', 'timeFrame': '30 days', 'description': 'freedom from death, type I/III endoleak, graft infection/thrombosis, aneurysm expansion and/or rupture, conversion to open repair, or new treatment-related thoraco-abdominal pathologies'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aneurysm']}, 'referencesModule': {'references': [{'pmid': '32081482', 'type': 'BACKGROUND', 'citation': 'Mirza AK, Tenorio ER, Karkkainen JM, Hofer J, Macedo T, Cha S, Ozbek P, Oderich GS. Learning curve of fenestrated and branched endovascular aortic repair for pararenal and thoracoabdominal aneurysms. J Vasc Surg. 2020 Aug;72(2):423-434.e1. doi: 10.1016/j.jvs.2019.09.046. Epub 2020 Feb 17.'}, {'pmid': '31882309', 'type': 'BACKGROUND', 'citation': 'Tenorio ER, Oderich GS, Farber MA, Schneider DB, Timaran CH, Schanzer A, Beck AW, Motta F, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium Investigators. Outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts. J Vasc Surg. 2020 Sep;72(3):822-836.e9. doi: 10.1016/j.jvs.2019.10.091. Epub 2019 Dec 25.'}, {'pmid': '25176618', 'type': 'BACKGROUND', 'citation': 'Oikonomou K, Kopp R, Katsargyris A, Pfister K, Verhoeven EL, Kasprzak P. Outcomes of fenestrated/branched endografting in post-dissection thoracoabdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):641-8. doi: 10.1016/j.ejvs.2014.07.005. Epub 2014 Aug 28.'}, {'pmid': '31882315', 'type': 'BACKGROUND', 'citation': 'Verzini F, Parlani G, Varetto G, Gibello L, Boero M, Torsello GF, Donas KP, Simonte G; pELVIS Investigators. Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: Results from the pELVIS Registry. J Vasc Surg. 2020 Aug;72(2):549-555.e1. doi: 10.1016/j.jvs.2019.09.065. Epub 2019 Dec 25.'}, {'pmid': '32173192', 'type': 'BACKGROUND', 'citation': 'Zhang J, Brier C, Parodi FE, Kuramochi Y, Lyden SP, Eagleton MJ. Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 Oct;72(4):1360-1366. doi: 10.1016/j.jvs.2019.12.040. Epub 2020 Mar 12.'}, {'pmid': '31901362', 'type': 'BACKGROUND', 'citation': 'Giosdekos A, Antonopoulos CN, Sfyroeras GS, Moulakakis KG, Tsilimparis N, Kakisis JD, Lazaris A, Chatziioannou A, Geroulakos G. The use of iliac branch devices for preservation of flow in internal iliac artery during endovascular aortic aneurysm repair. J Vasc Surg. 2020 Jun;71(6):2133-2144. doi: 10.1016/j.jvs.2019.10.087. Epub 2019 Dec 31.'}, {'pmid': '36822256', 'type': 'DERIVED', 'citation': 'Bertoglio L, Grandi A, Veraldi GF, Pulli R, Antonello M, Bonvini S, Isernia G, Bellosta R, Buia F, Silingardi R; COBRA Registry Collaborators. Midterm results on a new self-expandable covered stent combined with branched stent grafts: Insights from a multicenter Italian registry. J Vasc Surg. 2023 Jun;77(6):1598-1606.e3. doi: 10.1016/j.jvs.2023.02.007. Epub 2023 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the registry is to evaluate the peri-operative and short-, mid- and long-term outcomes of the Bard Covera Plus (Tempe, Arizona, USA) for the treatment of atherosclerotic aorto-iliac aneurysm in combination with a multibranched endograft'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '300 patients treated from January 2018 to January 2022 for atherosclerotic aorto-iliac aneurysm with procedures requiring the use of the Covera Plus covered stent in combination with a branched endograft', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≥18 years\n* Patients who underwent/will undergo a complex aortic procedure with the use of a Covera Plus covered stent graft as a bridging stent, in the centres involved in this Registry\n* Subject has consented for study participation and signed the approved Informed Consent\n\nExclusion Criteria:\n\n* Bleeding diathesis or coagulopathy\n* Patients with active systemic or cutaneous infection or inflammation\n* Patients who are pregnant or lactating\n* Patient younger than 18 years of age\n* Patients who did not receive treatment using a Covera Plus covered stent graft.'}, 'identificationModule': {'nctId': 'NCT04598802', 'briefTitle': 'COvera in BRAnch Registry', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'A Physician-initiated, Multicentre, Ambispective, Observational Registry of Patients Undergoing Complex Aortic Procedures With the Use of the Bard Covera Plus (Tempe, Arizona, USA) Covered Self-expandable Stents', 'orgStudyIdInfo': {'id': 'COBRA Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Covera Plus', 'interventionNames': ['Device: covered stent']}], 'interventions': [{'name': 'covered stent', 'type': 'DEVICE', 'description': 'atherosclerotic aorto-iliac aneurysm', 'armGroupLabels': ['Covera Plus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Heart & Vascular Center', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Ludwig-Maximilians University Hospital', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Asti', 'country': 'Italy', 'facility': 'Ospedale di Asti', 'geoPoint': {'lat': 44.90162, 'lon': 8.20751}}, {'city': 'Avellino', 'country': 'Italy', 'facility': 'Ospedale Giuseppe Moscati', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Consorziale Policlinico', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Fondazione Poliambulanza', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cosenza', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Cosenza', 'geoPoint': {'lat': 39.2989, 'lon': 16.25307}}, {'city': 'Cuneo', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Santa Croce e Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Ospedale civile San Giovanni di Dio', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Gaetano Martino', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Ospedale Cardarelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Ospedale Civico', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Parma', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Peschiera del Garda', 'country': 'Italy', 'facility': 'Ospedale Pederzoli', 'geoPoint': {'lat': 45.43912, 'lon': 10.68614}}, {'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Arcispedale Santa Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale San Camillo', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale San Filippo Neri', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale San Giovanni Addolorata Britannico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Umberto I', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'San Giovanni Rotondo', 'country': 'Italy', 'facility': 'Ospedale Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Trento', 'country': 'Italy', 'facility': 'Ospedale Santa Chiara', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}, {'city': 'Treviso', 'country': 'Italy', 'facility': "Ospedale Santa Maria di Ca' Foncello di Treviso", 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'city': 'Trieste', 'country': 'Italy', 'facility': 'Ospedale di Cattinara', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'Ospedale Borgo Roma', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Vicenza', 'country': 'Italy', 'facility': 'Ospedale San Bortolo di Vicenza', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bertoglio Luca', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}