Clinical trial NCT00870051: Endurant Stent Graft Natural Selection Global Postmarket Registry
Official title: Endurant Stent Graft Natural Selection Global Postmarket Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Keywords: Endurant
Stent Graft
Abdominal Aortic Aneurysm
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2009-03-26
Enrollment: 1266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with an AAA who are considered candidates for endovascular

Brief summary: The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years or minimum age as required by local regulations
* 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:

* High probability of non-adherence to physician's follow-up requirements
* Current participation in a concurrent trial which may confound study results

Primary outcomes:
measure: Treatment Success
timeFrame: 10 years
Secondary outcomes:
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
measure: AAA Diameter Increase
timeFrame: 10 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Clínica La Sagrada Familia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: St Andrew's Hospital
state: South Australia
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Epworth Healthcare - Epworth Eastern
state: Victoria
city: Nedlands
country: Australia
facility: JMLS Medical Services PTY, trading as Perth Institute of Vascular Research
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Perth
country: Australia
facility: Hollywood Private Hospital
state: Western Australia
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius-Campus Dendermonde
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
city: Montréal
country: Canada
facility: Glen Royal Victoria Hospital
city: Québec
country: Canada
facility: CHUQ - Hôpital Saint-François d'Assise
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Guangzhou
country: China
facility: People's Hospital of Guangdong Province
city: Bogotá
country: Colombia
facility: Fundacion Cardioinfantil
city: Praha
country: Czechia
facility: IKEM - Institutu Klinicke a Experimentalni Mediciny
city: Bordeaux
country: France
facility: CHU de Bordeaux - Centre Universitaire Pellegrin
city: Créteil
country: France
facility: Hôpitaux Universitaires - Hôpital Henri Mondor
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Münster
country: Germany
facility: St. Franziskus-Hospital Münster GmbH
city: Solingen
country: Germany
facility: Städtisches Klinikum Solingen
city: Thessaloníki
country: Greece
facility: Euromedica - Kyanous Stavros General Hospital
city: Thessaloníki
country: Greece
facility: Papageorgiou General Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: Policlinico Sant' Orsola - Malpighi
city: Firenze
country: Italy
facility: Azienda Ospedaliera-Universitaria Careggi
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University health System -Severence Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Arnhem
country: Netherlands
facility: Rijnstate - Locatie Arnhem
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum Heerlen
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Tilburg
country: Netherlands
facility: Sint-Elisabeth Ziekenhuis
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato District Health Board
city: Bergen
country: Norway
facility: Helse Bergen HF - Haukeland Universitetssjukehus
city: Oslo
country: Norway
facility: Oslo Universitetssykehus-Rikshospitalet
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
city: Warszawa
country: Poland
facility: Szpital Bielanski
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
city: Bratislava
country: Slovakia
facility: Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
city: Cape Town
country: South Africa
facility: Life Healthcare - Life Kingsbury Hospital
city: Port Elizabeth
country: South Africa
facility: Life Healthcare - Life St Georges Hospital
city: Pretoria
country: South Africa
facility: Netcare Unitas Hospital
city: Barcelona
country: Spain
facility: Hospital Universitari Clínic de Barcelona
city: Granada
country: Spain
facility: Complejo Hospitalario Universitario Granada Hospital Campus de la Salud
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Istanbul
country: Turkey
facility: Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Memorial Sisli Hastanesi
city: İzmir
country: Turkey
facility: Dokuz Eylül University
city: Yüreğir
country: Turkey
facility: Adana Baskent University Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
city: Liverpool
country: United Kingdom
facility: The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals - NHS Trust
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
city: Montevideo
country: Uruguay
facility: Institucion Medica Uruguaya
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Vicente Riambau, Prof.
role: STUDY_DIRECTOR
affiliation: Memorial Hospital Istanbul
name: Furuzan Numan, prof
role: STUDY_DIRECTOR
affiliation: The Queen Elizabeth Hospital, Woodville, South Adelaide, Australia
name: Robert A. Fitridge, Dr.
role: STUDY_DIRECTOR
affiliation: Tel Aviv Sourasky Medical Center, Israel
name: Yehuda Wolf, Prof.
role: STUDY_DIRECTOR
affiliation: Universtiy of Heidelberg, Germany
name: Dittmar Böckler, Prof.
role: STUDY_DIRECTOR
affiliation: Addenbrookes Hospital, Cambridge, Great Britain
name: Paul Hayes, Dr.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.