Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT03420066
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2018-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The NEXUS™ Compassionate Use Data Collection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094626', 'term': 'Aneurysm, Aortic Arch'}], 'ancestors': [{'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2018-01-28', 'studyFirstSubmitQcDate': '2018-01-28', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Evaluation Criteria', 'timeFrame': 'within 30 days post implantation', 'description': 'Device related mortality at 30 days post implantation based on review of medical charts by the Investigators'}, {'measure': 'Performance Evaluation Criteria', 'timeFrame': 'within 30 days post implantation', 'description': 'Successful disease treatment at 30 days post implantation, defined as Stent Graft positioned in the aortic arch isolating the diseased lesion based on review of medical charts by the Investigators.'}], 'secondaryOutcomes': [{'measure': 'Secondary Safety Evaluation Criteria', 'timeFrame': 'within 1 year post-implantation', 'description': 'Device related re-intervention (e.g. due to endoleak, stent graft occlusion, clinically significant migration) within 1 year from implantation and based on review of medical charts by the Investigators.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Arch Aneurysm']}, 'descriptionModule': {'briefSummary': 'A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.', 'detailedDescription': "The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexus™ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch.\n\nData will be collected at each time point of patient's follow up conducted according to the standard of care in each site."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will include all patients that were implanted with the Nexus device as part of the compassionate use.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients for whom the Nexus implantation was initiated as part of a compassionate use procedure.\n* A signed and dated Informed Consent document is available that authorizes to collect the patient's personal data following implantation of the Nexus systems and throughout the follow ups visits up to 5 years following implantation.\n\nExclusion Criteria:\n\n-There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above"}, 'identificationModule': {'nctId': 'NCT03420066', 'briefTitle': 'The NEXUS™ Compassionate Use Data Collection Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endospan Ltd.'}, 'officialTitle': 'NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures', 'orgStudyIdInfo': {'id': 'CIP008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective data collection', 'description': 'Group includes subjects that were implanted with the Nexus device as part of compassionate use procedure before joining the CIP008 study. Only intervention foreseen by CIP008 study is retrospective collection of data previously recorded as standard of care in medical charts (refer to Intervention/treatment section)', 'interventionNames': ['Other: Retrospective data collection']}], 'interventions': [{'name': 'Retrospective data collection', 'type': 'OTHER', 'description': 'Retrospective collection of data recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use duly authorized according to country specific regulations.', 'armGroupLabels': ['Retrospective data collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00135', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ospedale San Filippo Neri', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'ADHB Charitable Trust', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': 'CH-8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Klinik Hirslanden', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Zurich University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endospan Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}