Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT05324657
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2022-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'limb occlusion', 'timeFrame': '30 days', 'description': 'freedom from limb occlusion'}, {'measure': 'freedom from death', 'timeFrame': '30 days', 'description': 'survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal aortic aneurysm'], 'conditions': ['Aneurysm Abdominal']}, 'referencesModule': {'references': [{'pmid': '20484396', 'type': 'BACKGROUND', 'citation': 'De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.'}, {'pmid': '20382983', 'type': 'BACKGROUND', 'citation': 'United Kingdom EVAR Trial Investigators; Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1863-71. doi: 10.1056/NEJMoa0909305. Epub 2010 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'The aim was to determine, within the patient enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company) studies which are preoperative and postoperative anatomical risk factors associated to limb occlusion. In the three studies the total number of enrolled patients was 400, of whom 134 enrolled in the US'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All cases treated with Incraft who were enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company).\n\nThe patients will be compared in order to detect possible significant differences in terms of perioperative risk factors that could affect the study. Risk adjustment or other statistical tools might be used to create comparable cohorts.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with abdominal aortic aneurysm, who have been treated with the INCRAFT® Grafting System (AAA Stent-Graft System).\n* All cases treated with Incraft who were enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company)\n\nExclusion Criteria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT05324657', 'briefTitle': 'Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)', 'orgStudyIdInfo': {'id': 'LIMIT Study'}}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, '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'}}}}