Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT01810250
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2013-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endurant for Challenging Anatomy: Global Experience Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2013-03-11', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success', 'timeFrame': '12 months', 'description': 'Freedom from:\n\n* Increase of AAA diameter \\> 5 mm (1 month measurement as baseline)\n* Type I\\&III endoleaks\n* Aneurysm rupture\n* Conversion to surgery\n* Stent graft migration (\\>10mm) resulting in SAE or reintervention\n* Stent graft occlusion'}], 'secondaryOutcomes': [{'measure': 'Helath Related Quality of Life Scores', 'timeFrame': '12 months', 'description': 'EQ-5D VAS EQ-5D index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurysms With Challenging Anatomy']}, 'descriptionModule': {'briefSummary': 'The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database.\n\nThis study aims at answering two major questions:\n\n1. Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?\n2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with abdominal aortic aneurysms (AAAs) with challenging anatomy defined by having one or more of the following measurements:\n\n* Proximal necks 5 - 10mm in combination with \\< 60 degrees infrarenal AND \\< 45 degrees suprarenal angulation\n* Proximal necks 10 - 15mm in combination with 60 degrees - 75 degrees infrarenal AND \\< 60 degrees suprarenal angulation OR in combination with \\< 75 degrees infrarenal AND 45 degrees - 60 degrees suprarenal angulation\n* Proximal necks \\> 15mm in combination with 75 degrees - 90 degrees infrarenal AND \\< 75 degrees suprarenal angulation OR in combination with \\< 90 degrees infrarenal AND 60 degrees - 75 degrees suprarenal angulation', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years or minimum age as required by local regulations\n* Indication for elective EVAR\n* Challenging AAA anatomy\n* Intention to electively implant the Endurant or Endurant II Stent Graft System©\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Subjects with intolerance to contrast media\n* Chimneys or fenestrated device procedures\n* High probability of non-adherence to physician's follow-up requirements\n* Current participation in a concurrent trial that may confound study results"}, 'identificationModule': {'nctId': 'NCT01810250', 'acronym': 'EAGLE', 'briefTitle': 'Endurant for Challenging Anatomy: Global Experience Registry', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience', 'orgStudyIdInfo': {'id': 'EAGLE Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Abdominal Aortic Aneurysm (Challenging anatomy)', 'description': 'Endovascular aneurysm repair', 'interventionNames': ['Device: Endurant Stent Graft']}], 'interventions': [{'name': 'Endurant Stent Graft', 'type': 'DEVICE', 'armGroupLabels': ['Abdominal Aortic Aneurysm (Challenging anatomy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5602 ZA', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Joep Teijink', 'investigatorAffiliation': 'Catharina Ziekenhuis Eindhoven'}}}}