Endurant Stent Graft Natural Selection Global Postmarket Registry

NCT00870051 | Completed

• 1 other identifier: P#888
• Study Type: observational
• Target: 1,266
• Locations: 29 countries
• Sites: 71

Brief Summary

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

Conditions

Aortic Aneurysm, Abdominal

Keywords

Endurant; Stent Graft; Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Treatment Success

  10 years

Secondary Outcomes (13)

• Stent Graft Migration

  10 years

• Stent Graft Patency

  10 years

• Stent Graft Endoleaks

  10 years

• Secondary procedures to correct Type I and III endoleaks

  10 years

• Secondary endovascular procedure

  10 years

Study Arms (1)

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

Device: Endurant Stent Graft

Interventions

Endurant Stent Graft DEVICE

Endurant Stent Graft implantation

Also known as: EVAR

AAA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with an AAA who are considered candidates for endovascular

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (80)

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABD, Argentina

Location

Clínica La Sagrada Familia

Buenos Aires, C1426EOB, Argentina

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

St Andrew's Hospital

Adelaide, South Australia, 5000, Australia

Location

The Queen Elizabeth Hospital

Adelaide, South Australia, 5011, Australia

Location

Box Hill Hospital

Melbourne, Victoria, 3128, Australia

Location

Epworth Healthcare - Epworth Eastern

Melbourne, Victoria, 3128, Australia

Location

JMLS Medical Services PTY, trading as Perth Institute of Vascular Research

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6001, Australia

Location

Hollywood Private Hospital

Perth, Western Australia, 6009, Australia

Location

Krankenhaus Hietzing

Vienna, 1130, Austria

Location

Imeldaziekenhuis

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius-Campus Dendermonde

Dendermonde, 9200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Queen Elizabeth II Health Sciences Centre

Halifax, B3H 3A7, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, N6A 5W9, Canada

Location

Glen Royal Victoria Hospital

Montreal, H4A 3J1, Canada

Location

CHUQ - Hôpital Saint-François d'Assise

Québec, G1L 3L5, Canada

Location

Toronto General Hospital

Toronto, M5G 2C4, Canada

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

People's Hospital of Guangdong Province

Guangzhou, 510080, China

Location

Fundacion Cardioinfantil

Bogotá, Colombia

Location

IKEM - Institutu Klinicke a Experimentalni Mediciny

Prague, 140 21, Czechia

Location

CHU de Bordeaux - Centre Universitaire Pellegrin

Bordeaux, 33000, France

Location

Hôpitaux Universitaires - Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, 33604, France

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

St. Franziskus-Hospital Münster GmbH

Münster, 48145, Germany

Location

Städtisches Klinikum Solingen

Solingen, 42653, Germany

Location

Euromedica - Kyanous Stavros General Hospital

Thessaloniki, 54636, Greece

Location

Papageorgiou General Hospital

Thessaloniki, 56429, Greece

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Policlinico Sant' Orsola - Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliera-Universitaria Careggi

Florence, 50134, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

Rijnstate - Locatie Arnhem

Arnhem, 6815 AD, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Zuyderland Medisch Centrum Heerlen

Heerlen, 6419 PC, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

Sint-Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Waikato District Health Board

Hamilton, 3240, New Zealand

Location

Helse Bergen HF - Haukeland Universitetssjukehus

Bergen, 5021, Norway

Location

Oslo Universitetssykehus-Rikshospitalet

Oslo, 0027, Norway

Location

Universitetssykehuset Nord-Norge

Tromsø, 9019, Norway

Location

Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

Szczecin, 70-111, Poland

Location

Szpital Bielanski

Warsaw, 01-809, Poland

Location

Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

Lisbon, 1649-035, Portugal

Location

Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

Bratislava, 83348, Slovakia

Location

Life Healthcare - Life Kingsbury Hospital

Cape Town, 7700, South Africa

Location

Life Healthcare - Life St Georges Hospital

Port Elizabeth, 6001, South Africa

Location

Netcare Unitas Hospital

Pretoria, 0157, South Africa

Location

Chonnam National University Hospital

Gwangju, 102-602, South Korea

Location

Yonsei University health System -Severence Hospital

Seoul, 120-752, South Korea

Location

Hospital Universitari Clínic de Barcelona

Barcelona, 08036, Spain

Location

Complejo Hospitalario Universitario Granada Hospital Campus de la Salud

Granada, 18016, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47006, Spain

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

Universitetssjukhuset Örebro

Örebro, 701 85, Sweden

Location

Södersjukhuset

Stockholm, 118 83, Sweden

Location

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi

Istanbul, 34093, Turkey (Türkiye)

Location

Memorial Sisli Hastanesi

Istanbul, 34385, Turkey (Türkiye)

Location

Dokuz Eylül University

Izmir, 35220, Turkey (Türkiye)

Location

Adana Baskent University Hospital

Yüreğir, 01250, Turkey (Türkiye)

Location

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

St George's University Hospitals - NHS Trust

London, SW17 0QT, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Institucion Medica Uruguaya

Montevideo, Uruguay

Location

Related Publications (12)

• 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: 20671632 RESULT

• 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: 22835762 RESULT

• 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: 22440235 RESULT

• 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: 23266281 RESULT

• 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: 22459746 RESULT

• 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: 23581758 RESULT

• 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: 24657065 RESULT

• 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: 25282698 RESULT

• 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: 25656594 RESULT

• 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: 31443976 DERIVED

• 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: 27170150 DERIVED

• 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.

  PMID: 25937606 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Vicente Riambau, Prof.

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

• Furuzan Numan, prof

  Memorial Hospital Istanbul

  STUDY DIRECTOR

• Robert A. Fitridge, Dr.

  The Queen Elizabeth Hospital, Woodville, South Adelaide, Australia

  STUDY DIRECTOR

• Yehuda Wolf, Prof.

  Tel Aviv Sourasky Medical Center, Israel

  STUDY DIRECTOR

• Dittmar Böckler, Prof.

  Universtiy of Heidelberg, Germany

  STUDY DIRECTOR

• Paul Hayes, Dr.

  Addenbrookes Hospital, Cambridge, Great Britain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: April 8, 2009
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); IT (3); AR (2); NZ (2); CZ (1); IL (1); BE (4); TH (1); NL (6); NO (3); CO (1); CA (5); DE (3); GB (5); SL (1); PT (1); SE (3); TU (4); UR (1); CH (1); PL (2); FR (3); ZA (3); GR (2); LI (1); HK (1); ES (5); KR (2); CN (3)