Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT04564560
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2020-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000094682', 'term': 'Endovascular Aneurysm Repair'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019917', 'term': 'Blood Vessel Prosthesis Implantation'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2020-09-22', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients who have got treated post-surgery due to thrombosis or occlusion of stent graft leg', 'timeFrame': '12-36 months', 'description': 'Any endovascular or surgical procedure to treat thrombosis or occlusion'}, {'measure': 'Percentage of patients who got an amputation post-surgery due to thrombosis or occlusion of stent graft leg', 'timeFrame': '12-36 months', 'description': 'Any amputation in the affected limb / same side as thrombosed stent graft leg'}, {'measure': 'Percentage of patients who died post-surgery', 'timeFrame': '12-36 months', 'description': 'Death of any cause during the observation time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stents', 'Thrombosis'], 'conditions': ['Aorta Aneurysm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.', 'detailedDescription': 'Cook Medical has reported thrombus formation with or without occlusion of the Zenith Alpha Spiral-Z®. The purpose of this study is to measure the extent of thrombus formation and occlusion of these stent graft limbs in patients with aortic aneurysms treated at St. Olavs Hospital in 2017, 2018 and 2019. Information is collected from the Norwegian registry for vascular surgery (NORKAR), electronic patient journal and the picture archiving and communication system (PACS). The total number of included patients is estimated to be approximately 100.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patient treated at St. Olavs Hospital in the period January 2017 until December 2019 with endovascular aortic repair using the Zenith Alpha Spiral-Z® .', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that have received endovascular treatment with the Zenith Alpha Spiral-Z® for an aortic aneurysm\n* The endovascular procedure was performed at St Olavs Hospital from January 2017 until December 2019\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04564560', 'briefTitle': 'Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®', 'orgStudyIdInfo': {'id': '137828'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with Zenith Alpha Spiral-Z®', 'description': 'Patients that from January 2017 until December 2019 received endovascular aortic repair with the Zenith Alpha Spiral-Z® at St. Olavs Hospital', 'interventionNames': ['Procedure: Endovascular aortic repair with Zenith Alpha Spiral-Z®']}], 'interventions': [{'name': 'Endovascular aortic repair with Zenith Alpha Spiral-Z®', 'type': 'PROCEDURE', 'description': 'The Zenith Alpha Spiral-Z® stent graft may have an increased risk of thrombosis. The intervention in this study is to assess the extent and degree of thrombosis in patients treated with the Zenith Alpha Spiral-Z® during endovascular repair of aortic aneurysm', 'armGroupLabels': ['Patients treated with Zenith Alpha Spiral-Z®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Morten Troøyen, md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St Olavs Hospital, Dept Radiology and Nuclear Medicine'}, {'name': 'Birger H Endreseth, md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St Olavs Hospital, Dept Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}