Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT03620006
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2018-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subclavian Artery Plug Embolization (SAPE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2018-05-21', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': 'within 30-day', 'description': 'Technical success rate defined as complete occlusion of the left subclavian artery at postoperative CT scan'}, {'measure': 'Major adverse event rate', 'timeFrame': 'within 30-day', 'description': 'Any stroke or mortality related to the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Access site complications requiring secondary adjunctive procedures', 'timeFrame': 'within 30-day', 'description': 'Any access site complication requiring open or endovascular adjuctive procedures (ie: surgical embolectomy, echo-guided pseudoaneurysm manual compression)'}, {'measure': 'Supra-aortic vessels patency rate', 'timeFrame': 'within 5-years', 'description': 'Patency of the carotid and subaclavian artery at follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subclavian Artery Plug Embolization']}, 'referencesModule': {'references': [{'pmid': '31630886', 'type': 'DERIVED', 'citation': 'Bertoglio L, Salvati S, Fittipaldi A, Melloni A, Kahlberg A, Cambiaghi T, Melissano G, Chiesa R. Carotid to subclavian bypass and Amplatzer vascular plug subclavian endovascular occlusion before thoracic open or endovascular repair. J Vasc Surg. 2020 May;71(5):1480-1488.e1. doi: 10.1016/j.jvs.2019.08.237. Epub 2019 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational, no-profit, ambispective study: a retrospective arm will include the cases treated between August 2009 and March 2018, and a prospective arm, investigating patients treated from March 2018 until December 2018. Target study population size is 150 patients between two groups analyzed.\n\nEndovascular occlusion of the prevertebral subclavian artery was first used in the Vascular Surgery Department at San Raffaele Hospital in August 2009. During the initial experience (2009-2014) this technique was used with low frequency. Since 2015, the volume of cases receiving this treatment, has increased and the investigators expect to reach the study population target, by the end of 2018.\n\nThe objective of this study is describe the casuistry of endovascular occlusion of the subclavian artery by means of the Amplatzer Vascular plug in the Vascular Surgery Department at San Raffaele Hospital, and to evaluate the efficacy of such procedure.\n\nMoreover, the investigators will evaluate the patency and success rate of the carotid-subclavian bypasses performed at the same time of the analyzed procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients aged ≥ 18 years, candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients aged ≥ 18 years,\n* patients candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug\n\nExclusion Criteria:\n\n• none'}, 'identificationModule': {'nctId': 'NCT03620006', 'acronym': 'SAPE', 'briefTitle': 'Subclavian Artery Plug Embolization (SAPE)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Endovascular Occlusion by Plug of the Prevertebral Subclavian Artery Preparatory to the Surgical or Endovascular Aortic Procedures (SAPE)', 'orgStudyIdInfo': {'id': 'SAPE'}}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bertoglio Luca', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}