Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-06 @ 10:09 PM
Study NCT ID:
NCT02438605
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic CT Imaging After Nellix Endoprosthesis Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-30', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-05-06', 'lastUpdatePostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Dynamic changes in neck morphology after EVAS', 'timeFrame': '1 month'}, {'measure': 'Dynamic changes in common iliac artery morphology after EVAS.', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nellix', 'EVAS', 'EVAR', 'Dynamic CT', 'Dyna CT'], 'conditions': ['Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and post-operative will be assessed for device changes and anatomical variances.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients eligible for endovascular aortic repair using the Nellix endovascular sealing system', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nellix implantation\n\nExclusion Criteria:\n\n* Use of chimneys or combined with other stent graft material'}, 'identificationModule': {'nctId': 'NCT02438605', 'briefTitle': 'Dynamic CT Imaging After Nellix Endoprosthesis Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Dynamic CT Imaging After Nellix Endoprosthesis Implantation', 'orgStudyIdInfo': {'id': 'StM 596'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment group', 'description': 'Patients eligible for AAA repair using Nellix and willing to participate in this trial.', 'interventionNames': ['Device: Nellix']}], 'interventions': [{'name': 'Nellix', 'type': 'DEVICE', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6815AD', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., PhD.', 'investigatorFullName': 'Michel Reijnen', 'investigatorAffiliation': 'Rijnstate Hospital'}}}}