Endurant Stent Graft Natural Selection Global Postmarket Registry

Aortic Aneurysm, Abdominal Clinical Trial

— ENGAGE  

Official title:

Endurant Stent Graft Natural Selection Global Postmarket Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870051
• Other study ID #: P#888
• Status: Completed
• Start date: April 8, 2009
• Est. completion date: September 23, 2021

Study information

• Verified date: January 2022
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1266
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Endurant Stent Graft
Endurant Stent Graft implantation

Locations

Country	Name	City	State
Argentina	Clínica La Sagrada Familia	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Australia	St Andrew's Hospital	Adelaide	South Australia
Australia	The Queen Elizabeth Hospital	Adelaide	South Australia
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
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	Hollywood Private Hospital	Perth	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Austria	Krankenhaus Hietzing	Wien
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	AZ Sint-Blasius-Campus Dendermonde	Dendermonde
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Gent	Gent
Canada	Queen Elizabeth II Health Sciences Centre	Halifax
Canada	London Health Sciences Centre - Victoria Hospital	London
Canada	Glen Royal Victoria Hospital	Montréal
Canada	CHUQ - Hôpital Saint-François d'Assise	Québec
Canada	Toronto General Hospital	Toronto
China	Chinese PLA General Hospital	Beijing
China	West China Hospital of Sichuan University	Chengdu
China	People's Hospital of Guangdong Province	Guangzhou
Colombia	Fundacion Cardioinfantil	Bogotá
Czechia	IKEM - Institutu Klinicke a Experimentalni Mediciny	Praha
France	CHU de Bordeaux - Centre Universitaire Pellegrin	Bordeaux
France	Hôpitaux Universitaires - Hôpital Henri Mondor	Créteil
France	Hôpital Haut-Lévêque - CHU de Bordeaux	Pessac
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	St. Franziskus-Hospital Münster GmbH	Münster
Germany	Städtisches Klinikum Solingen	Solingen
Greece	Euromedica - Kyanous Stavros General Hospital	Thessaloníki
Greece	Papageorgiou General Hospital	Thessaloníki
Hong Kong	Queen Mary Hospital	Hong Kong
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Policlinico Sant' Orsola - Malpighi	Bologna
Italy	Azienda Ospedaliera-Universitaria Careggi	Firenze
Italy	Azienda Ospedaliera Universitaria Senese	Siena
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Yonsei University health System -Severence Hospital	Seoul
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Netherlands	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
New Zealand	Auckland City Hospital	Auckland
New Zealand	Waikato District Health Board	Hamilton
Norway	Helse Bergen HF - Haukeland Universitetssjukehus	Bergen
Norway	Oslo Universitetssykehus-Rikshospitalet	Oslo
Norway	Universitetssykehuset Nord-Norge	Tromsø
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie	Szczecin
Poland	Szpital Bielanski	Warszawa
Portugal	Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE	Lisboa
Slovakia	Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)	Bratislava
South Africa	Life Healthcare - Life Kingsbury Hospital	Cape Town
South Africa	Life Healthcare - Life St Georges Hospital	Port Elizabeth
South Africa	Netcare Unitas Hospital	Pretoria
Spain	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
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg
Sweden	Universitetssjukhuset Örebro	Örebro
Sweden	Södersjukhuset	Stockholm
Switzerland	Inselspital - Universitätsspital Bern	Bern
Thailand	Songklanagarind Hospital	Songkhla
Turkey	Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi	Istanbul
Turkey	Memorial Sisli Hastanesi	Istanbul
Turkey	Dokuz Eylül University	Izmir
Turkey	Adana Baskent University Hospital	Yüregir
United Kingdom	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
Uruguay	Institucion Medica Uruguaya	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Canada,  China,  Colombia,  Czechia,  France,  Germany,  Greece,  Hong Kong,  Israel,  Italy,  Korea, Republic of,  Lithuania,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Thailand,  Turkey,  United Kingdom,  Uruguay, 

References & Publications (9)

Böckler 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 en — View 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. — View 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. Review. — View Citation

Kiguchi MM, Forbes TL, Teijink JA, Pliagas GA, Ellozy SH, Böckler 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. — View 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 octog — View 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 R — View 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: 10.10 — View Citation

Stokmans RA, Teijink JA, Forbes TL, Böckler 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 Su — View 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):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success		10 years
Secondary	Stent Graft Migration		10 years
Secondary	Stent Graft Patency		10 years
Secondary	Stent Graft Endoleaks		10 years
Secondary	Secondary procedures to correct Type I and III endoleaks		10 years
Secondary	Secondary endovascular procedure		10 years
Secondary	Adverse Device Effects		10 years
Secondary	Technical Observations		5 years
Secondary	Aneurysm-related mortality		10 years
Secondary	All-cause mortality		10 years
Secondary	MAE		30 days
Secondary	Health Related Quality of Life Scores		12 months
Secondary	Stent Graft Stenosis	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.	10 years
Secondary	AAA Diameter Increase		10 years