Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00870051
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2009-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endurant Stent Graft Natural Selection Global Postmarket Registry
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': 1266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-26', 'studyFirstSubmitDate': '2009-03-25', 'studyFirstSubmitQcDate': '2009-03-25', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Success', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Stent Graft Migration', 'timeFrame': '10 years'}, {'measure': 'Stent Graft Patency', 'timeFrame': '10 years'}, {'measure': 'Stent Graft Endoleaks', 'timeFrame': '10 years'}, {'measure': 'Secondary procedures to correct Type I and III endoleaks', 'timeFrame': '10 years'}, {'measure': 'Secondary endovascular procedure', 'timeFrame': '10 years'}, {'measure': 'Adverse Device Effects', 'timeFrame': '10 years'}, {'measure': 'Technical Observations', 'timeFrame': '5 years'}, {'measure': 'Aneurysm-related mortality', 'timeFrame': '10 years'}, {'measure': 'All-cause mortality', 'timeFrame': '10 years'}, {'measure': 'MAE', 'timeFrame': '30 days'}, {'measure': 'Health Related Quality of Life Scores', 'timeFrame': '12 months'}, {'measure': 'Stent Graft Stenosis', 'timeFrame': '10 years', 'description': 'Stent Graft stenosis is considered a reduction in the diameter of the stent graft lumen as compared to the reference. SG stenosis will be assessed by imaging as CT with contrast, Ultrasound, etc.'}, {'measure': 'AAA Diameter Increase', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endurant', 'Stent Graft', 'Abdominal Aortic Aneurysm'], 'conditions': ['Aortic Aneurysm, Abdominal']}, 'referencesModule': {'references': [{'pmid': '20671632', 'type': 'RESULT', 'citation': 'Bockler D, Fitridge R, Wolf Y, Hayes P, Silveira PG, Numan F, Riambau V; ENGAGE Investigators. Rationale and design of the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE): interim analysis at 30 days of the first 180 patients enrolled. J Cardiovasc Surg (Torino). 2010 Aug;51(4):481-91.'}, {'pmid': '22835762', 'type': 'RESULT', 'citation': 'Stokmans RA, Teijink JA, Forbes TL, Bockler D, Peeters PJ, Riambau V, Hayes PD, van Sambeek MR. Early results from the ENGAGE registry: real-world performance of the Endurant Stent Graft for endovascular AAA repair in 1262 patients. Eur J Vasc Endovasc Surg. 2012 Oct;44(4):369-75. doi: 10.1016/j.ejvs.2012.07.005. Epub 2012 Jul 24.'}, {'pmid': '22440235', 'type': 'RESULT', 'citation': 'Stokmans RA, Teijink JA, Cuypers PW, Riambau V, van Sambeek MR. No differences in perioperative outcome between symptomatic and asymptomatic AAAs after EVAR: an analysis from the ENGAGE Registry. Eur J Vasc Endovasc Surg. 2012 Jun;43(6):667-73. doi: 10.1016/j.ejvs.2012.02.034. Epub 2012 Mar 21.'}, {'pmid': '23266281', 'type': 'RESULT', 'citation': 'Dubois L, Novick TV, Harris JR, Derose G, Forbes TL. Outcomes after endovascular abdominal aortic aneurysm repair are equivalent between genders despite anatomic differences in women. J Vasc Surg. 2013 Feb;57(2):382-389.e1. doi: 10.1016/j.jvs.2012.09.075. Epub 2012 Dec 21.'}, {'pmid': '22459746', 'type': 'RESULT', 'citation': 'Pol RA, Zeebregts CJ, van Sterkenburg SM, Reijnen MM; ENGAGE Investigators. Thirty-day outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians based on the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). J Vasc Surg. 2012 Jul;56(1):27-35. doi: 10.1016/j.jvs.2011.12.080. Epub 2012 Mar 28.'}, {'pmid': '23581758', 'type': 'RESULT', 'citation': 'Tang T, Sadat U, Walsh S, Hayes PD; ENGAGE Investigators. Comparison of the endurant bifurcated endograft vs. aortouni-iliac stent-grafting in patients with abdominal aortic aneurysms: experience from the ENGAGE registry. J Endovasc Ther. 2013 Apr;20(2):172-81. doi: 10.1583/1545-1550-20.2.172.'}, {'pmid': '24657065', 'type': 'RESULT', 'citation': 'Pol RA, Zeebregts CJ, van Sterkenburg SM, Ferreira LM, Goktay Y, Reijnen MM; Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) Investigators. Outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians. J Vasc Surg. 2014 Aug;60(2):308-17. doi: 10.1016/j.jvs.2014.02.009. Epub 2014 Mar 20.'}, {'pmid': '25282698', 'type': 'RESULT', 'citation': 'Kiguchi MM, Forbes TL, Teijink JA, Pliagas GA, Ellozy SH, Bockler D, Makaroun MS. Clinical application and early outcomes of the aortouni-iliac configuration for endovascular aneurysm repair. J Vasc Surg. 2014 Dec;60(6):1452-9. doi: 10.1016/j.jvs.2014.08.063. Epub 2014 Oct 3.'}, {'pmid': '25656594', 'type': 'RESULT', 'citation': 'Faure EM, Becquemin JP, Cochennec F; ENGAGE collaborators. Predictive factors for limb occlusions after endovascular aneurysm repair. J Vasc Surg. 2015 May;61(5):1138-45.e2. doi: 10.1016/j.jvs.2014.11.084. Epub 2015 Feb 2.'}, {'pmid': '31443976', 'type': 'DERIVED', 'citation': 'Dijkstra ML, Zeebregts CJ, Verhagen HJM, Teijink JAW, Power AH, Bockler D, Peeters P, Riambau V, Becquemin JP, Reijnen MMPJ; ENGAGE investigators. Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data. J Vasc Surg. 2020 Mar;71(3):780-789. doi: 10.1016/j.jvs.2019.04.486. Epub 2019 Aug 20.'}, {'pmid': '27170150', 'type': 'DERIVED', 'citation': 'Dijkstra ML, van Sterkenburg SM, Lardenoye JW, Zeebregts CJ, Reijnen MM; ENGAGE Investigators. One-Year Outcomes of Endovascular Aneurysm Repair in High-Risk Patients Using the Endurant Stent-Graft: Comparison of the ASA Classification and SVS/AAVS Medical Comorbidity Grading System for the Prediction of Mortality and Adverse Events. J Endovasc Ther. 2016 Aug;23(4):574-82. doi: 10.1177/1526602816648455. Epub 2016 May 10.'}, {'pmid': '25937606', 'type': 'DERIVED', 'citation': 'Broos PP, Stokmans RA, van Sterkenburg SM, Torsello G, Vermassen F, Cuypers PW, van Sambeek MR, Teijink JA. Performance of the Endurant stent graft in challenging anatomy. J Vasc Surg. 2015 Aug;62(2):312-8. doi: 10.1016/j.jvs.2015.03.024. Epub 2015 May 1.'}]}, 'descriptionModule': {'briefSummary': "The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.", 'detailedDescription': "The Endurant Stent Graft Natural Selection Global Post-market Registry, ENGAGE is initiated to expand the clinical knowledge base by including 'real world' subjects, applying a minimal amount of subject selection criteria. This subject group may better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases. ENGAGE aims at following and documenting the subject selections, diagnostic tools used and treatment interventions chosen by the vascular surgeon or interventional radiologist. ENGAGE will not impose CIP required study procedures affecting clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects diagnosed with an AAA who are considered candidates for endovascular', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years or minimum age as required by local regulations\n* Indication for elective surgical repair of AAA with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System\n* Signed consent form ("Patient informed consent Form" or "Patient Data Release Authorization Form"). The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information\n* Intention to electively implant the ENDURANT Stent Graft System\n* Ability and willingness to comply with the CIP.\n\nExclusion Criteria:\n\n* High probability of non-adherence to physician\'s follow-up requirements\n* Current participation in a concurrent trial which may confound study results'}, 'identificationModule': {'nctId': 'NCT00870051', 'acronym': 'ENGAGE', 'briefTitle': 'Endurant Stent Graft Natural Selection Global Postmarket Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'Endurant Stent Graft Natural Selection Global Postmarket Registry', 'orgStudyIdInfo': {'id': 'P#888'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AAA patients', 'description': 'Subjects diagnosed with an AAA who are considered candidates for endovascular repair with Endurant Stent Graft, and who meet the inclusion/exclusion criteria are intended to participate in this registry', 'interventionNames': ['Device: Endurant Stent Graft']}], 'interventions': [{'name': 'Endurant Stent Graft', 'type': 'DEVICE', 'otherNames': ['EVAR'], 'description': 'Endurant Stent Graft implantation', 'armGroupLabels': ['AAA patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1199ABD', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426EOB', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clínica La Sagrada Familia', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': "St Andrew's Hospital", 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5011', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3128', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Box Hill Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3128', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Epworth Healthcare - Epworth Eastern', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'JMLS Medical Services PTY, trading as Perth Institute of Vascular Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '6001', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Hollywood Private Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Krankenhaus Hietzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imeldaziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '9200', 'city': 'Dendermonde', 'country': 'Belgium', 'facility': 'AZ Sint-Blasius-Campus Dendermonde', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'N6A 5W9', 'city': 'London', 'country': 'Canada', 'facility': 'London Health Sciences Centre - 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