Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-01 @ 10:17 PM
Study NCT ID:
NCT05626504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-22', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate 30-day morbidity rates', 'timeFrame': 'Done at 30 days post procedural', 'description': 'We will evaluate short term clinical outcome in the form of morbidity rates 30 days after the procedure'}, {'measure': 'Evaluate 30-day mortality rates', 'timeFrame': 'Done at 30 days post procedural', 'description': 'We will evaluate short term clinical outcome in the form of mortality rates 30 days after the procedure'}], 'secondaryOutcomes': [{'measure': 'Evaluate 1-year morbidity rates', 'timeFrame': 'Done at >30days up to 1 year post procedural', 'description': 'We will evaluate long term clinical outcome in the form of morbidity rates \\>30days up to 1 year after the procedure'}, {'measure': 'Evaluate 1-year mortality rates', 'timeFrame': 'Done at >30days up to 1 year post procedural', 'description': 'We will evaluate long term clinical outcome in the form of mortality rates \\>30days up to 1 year after the procedure'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Brain Aneurysm', 'Intracranial Hemorrhages', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '31727754', 'type': 'BACKGROUND', 'citation': 'Atasoy D, Kandasamy N, Hart J, Lynch J, Yang SH, Walsh D, Tolias C, Booth TC. Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU). AJNR Am J Neuroradiol. 2019 Dec;40(12):2094-2101. doi: 10.3174/ajnr.A6314. Epub 2019 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'In this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Treated with pipeline embolization devices during 2021 and 2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV)\n* MRA and/or DSA (or tomographic angiography) available for follow up\n\nExclusion Criteria:\n\n* Insufficient background data available e.g., to determine size of aneurysm and pipeline device\n* PEDV used for causes other than aneurysms, e.g., fistulas and dissection.'}, 'identificationModule': {'nctId': 'NCT05626504', 'acronym': 'PEDVU', 'briefTitle': 'Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms', 'orgStudyIdInfo': {'id': '317314'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pipeline Embolization Device with Vantage Technology', 'type': 'DEVICE', 'description': 'Flow-diverter device occludes aneurysms through endoluminal reconstruction and remodelling of the parent artery.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}