Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT01398332
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2011-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the GORE® C3 Delivery System Module
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate procedural outcomes for the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System when used in accordance with the standard medical practice at each participating hospital.', 'timeFrame': 'Up to 10 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Aortic Aneurysm, Abdominal']}, 'descriptionModule': {'briefSummary': 'This is an observational Registry designed to obtain early data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.', 'detailedDescription': 'This is a retrospective and prospective observational cohort Registry designed to obtain data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System. Patient and device performance outcomes will be collected during treatment and throughout all post-treatment visits, including follow-up extending up to 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo endovascular treatment for aortic pathologies with the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Minimum age required by local regulations (as applicable)\n2. Indication for aortic endovascular stent graft repair as determined by the treating physician (refer to current Instructions for Use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System)'}, 'identificationModule': {'nctId': 'NCT01398332', 'briefTitle': 'Evaluation of the GORE® C3 Delivery System Module', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'Global Registry for Endovascular Aortic Treatment (GREAT)', 'orgStudyIdInfo': {'id': 'GRT 10-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aortic pathologies', 'description': 'Indication for aortic endovascular stent graft repair', 'interventionNames': ['Device: Stent graft (EXCLUDER)']}], 'interventions': [{'name': 'Stent graft (EXCLUDER)', 'type': 'DEVICE', 'otherNames': ['EXCLUDER'], 'description': 'Endovascular repair', 'armGroupLabels': ['Aortic pathologies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90471', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Klinikum Nürnberg-Süd', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Eric Verhoeven, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Nürnberg-Süd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}