Endurant Stent Graft Natural Selection Global Postmarket Registry
NCT ID: NCT00870051
Last Updated: 2022-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1266 participants
OBSERVATIONAL
2009-04-08
2021-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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AAA patients
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
Endurant Stent Graft
Endurant Stent Graft implantation
Interventions
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Endurant Stent Graft
Endurant Stent Graft implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Intention to electively implant the ENDURANT Stent Graft System
* Ability and willingness to comply with the CIP.
Exclusion Criteria
* Current participation in a concurrent trial which may confound study results
18 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Vicente Riambau, Prof.
Role: STUDY_DIRECTOR
Hospital Clinic of Barcelona
Furuzan Numan, prof
Role: STUDY_DIRECTOR
Memorial Hospital Istanbul
Robert A. Fitridge, Dr.
Role: STUDY_DIRECTOR
The Queen Elizabeth Hospital, Woodville, South Adelaide, Australia
Yehuda Wolf, Prof.
Role: STUDY_DIRECTOR
Tel Aviv Sourasky Medical Center, Israel
Dittmar Böckler, Prof.
Role: STUDY_DIRECTOR
Universtiy of Heidelberg, Germany
Paul Hayes, Dr.
Role: STUDY_DIRECTOR
Addenbrookes Hospital, Cambridge, Great Britain
Locations
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Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Clínica La Sagrada Familia
Buenos Aires, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
St Andrew's Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
Epworth Healthcare - Epworth Eastern
Melbourne, Victoria, Australia
JMLS Medical Services PTY, trading as Perth Institute of Vascular Research
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Hollywood Private Hospital
Perth, Western Australia, Australia
Krankenhaus Hietzing
Vienna, , Austria
Imeldaziekenhuis
Bonheiden, , Belgium
AZ Sint-Blasius-Campus Dendermonde
Dendermonde, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Queen Elizabeth II Health Sciences Centre
Halifax, , Canada
London Health Sciences Centre - Victoria Hospital
London, , Canada
Glen Royal Victoria Hospital
Montreal, , Canada
CHUQ - Hôpital Saint-François d'Assise
Québec, , Canada
Toronto General Hospital
Toronto, , Canada
Chinese PLA General Hospital
Beijing, , China
West China Hospital of Sichuan University
Chengdu, , China
People's Hospital of Guangdong Province
Guangzhou, , China
Fundacion Cardioinfantil
Bogotá, , Colombia
IKEM - Institutu Klinicke a Experimentalni Mediciny
Prague, , Czechia
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux, , France
Hôpitaux Universitaires - Hôpital Henri Mondor
Créteil, , France
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, , France
Universitätsklinikum Heidelberg
Heidelberg, , Germany
St. Franziskus-Hospital Münster GmbH
Münster, , Germany
Städtisches Klinikum Solingen
Solingen, , Germany
Euromedica - Kyanous Stavros General Hospital
Thessaloniki, , Greece
Papageorgiou General Hospital
Thessaloniki, , Greece
Queen Mary Hospital
Hong Kong, , Hong Kong
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Policlinico Sant' Orsola - Malpighi
Bologna, , Italy
Azienda Ospedaliera-Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Rijnstate - Locatie Arnhem
Arnhem, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Zuyderland Medisch Centrum Heerlen
Heerlen, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Sint-Elisabeth Ziekenhuis
Tilburg, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Waikato District Health Board
Hamilton, , New Zealand
Helse Bergen HF - Haukeland Universitetssjukehus
Bergen, , Norway
Oslo Universitetssykehus-Rikshospitalet
Oslo, , Norway
Universitetssykehuset Nord-Norge
Tromsø, , Norway
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, , Poland
Szpital Bielanski
Warsaw, , Poland
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
Lisbon, , Portugal
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
Bratislava, , Slovakia
Life Healthcare - Life Kingsbury Hospital
Cape Town, , South Africa
Life Healthcare - Life St Georges Hospital
Port Elizabeth, , South Africa
Netcare Unitas Hospital
Pretoria, , South Africa
Chonnam National University Hospital
Gwangju, , South Korea
Yonsei University health System -Severence Hospital
Seoul, , South Korea
Hospital Universitari Clínic de Barcelona
Barcelona, , Spain
Complejo Hospitalario Universitario Granada Hospital Campus de la Salud
Granada, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Universitetssjukhuset Örebro
Örebro, , Sweden
Södersjukhuset
Stockholm, , Sweden
Inselspital - Universitätsspital Bern
Bern, , Switzerland
Songklanagarind Hospital
Songkhla, , Thailand
Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Memorial Sisli Hastanesi
Istanbul, , Turkey (Türkiye)
Dokuz Eylül University
Izmir, , Turkey (Türkiye)
Adana Baskent University Hospital
Yüreğir, , Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, , United Kingdom
The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
Liverpool, , United Kingdom
St George's University Hospitals - NHS Trust
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Institucion Medica Uruguaya
Montevideo, , Uruguay
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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P#888
Identifier Type: -
Identifier Source: org_study_id
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