Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurant Stent Graft | Device | Endurant Stent Graft implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Graft Migration | 10 years | |
| Stent Graft Patency | 10 years | |
| Stent Graft Endoleaks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects diagnosed with an AAA who are considered candidates for endovascular
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Buenos Aires | C1199ABD | Argentina | |||
| Clínica La Sagrada Familia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20671632 | Result | 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. | |
| 22835762 | Result |
Not provided
Not provided
Only multi center data will be available
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 10 years |
| Secondary procedures to correct Type I and III endoleaks | 10 years |
| Secondary endovascular procedure | 10 years |
| Adverse Device Effects | 10 years |
| Technical Observations | 5 years |
| Aneurysm-related mortality | 10 years |
| All-cause mortality | 10 years |
| MAE | 30 days |
| Health Related Quality of Life Scores | 12 months |
| 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 |
| AAA Diameter Increase | 10 years |
| Buenos Aires |
| C1426EOB |
| Argentina |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Royal Brisbane and Women's Hospital | Brisbane | Queensland | 4029 | Australia |
| St Andrew's Hospital | Adelaide | South Australia | 5000 | Australia |
| The Queen Elizabeth Hospital | Adelaide | South Australia | 5011 | Australia |
| Box Hill Hospital | Melbourne | Victoria | 3128 | Australia |
| Epworth Healthcare - Epworth Eastern | Melbourne | Victoria | 3128 | Australia |
| JMLS Medical Services PTY, trading as Perth Institute of Vascular Research | Nedlands | Western Australia | 6009 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6001 | Australia |
| Hollywood Private Hospital | Perth | Western Australia | 6009 | Australia |
| Krankenhaus Hietzing | Vienna | 1130 | Austria |
| Imeldaziekenhuis | Bonheiden | 2820 | Belgium |
| AZ Sint-Blasius-Campus Dendermonde | Dendermonde | 9200 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Queen Elizabeth II Health Sciences Centre | Halifax | B3H 3A7 | Canada |
| London Health Sciences Centre - Victoria Hospital | London | N6A 5W9 | Canada |
| Glen Royal Victoria Hospital | Montreal | H4A 3J1 | Canada |
| CHUQ - Hôpital Saint-François d'Assise | Québec | G1L 3L5 | Canada |
| Toronto General Hospital | Toronto | M5G 2C4 | Canada |
| Chinese PLA General Hospital | Beijing | 100853 | China |
| West China Hospital of Sichuan University | Chengdu | 610041 | China |
| People's Hospital of Guangdong Province | Guangzhou | 510080 | China |
| Fundacion Cardioinfantil | Bogotá | Colombia |
| IKEM - Institutu Klinicke a Experimentalni Mediciny | Prague | 140 21 | Czechia |
| CHU de Bordeaux - Centre Universitaire Pellegrin | Bordeaux | 33000 | France |
| Hôpitaux Universitaires - Hôpital Henri Mondor | Créteil | 94010 | France |
| Hôpital Haut-Lévêque - CHU de Bordeaux | Pessac | 33604 | France |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| St. Franziskus-Hospital Münster GmbH | Münster | 48145 | Germany |
| Städtisches Klinikum Solingen | Solingen | 42653 | Germany |
| Euromedica - Kyanous Stavros General Hospital | Thessaloniki | 54636 | Greece |
| Papageorgiou General Hospital | Thessaloniki | 56429 | Greece |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Policlinico Sant' Orsola - Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliera-Universitaria Careggi | Florence | 50134 | Italy |
| Azienda Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
| Vilnius University Hospital Santaros Klinikos | Vilnius | 08661 | Lithuania |
| Rijnstate - Locatie Arnhem | Arnhem | 6815 AD | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| Zuyderland Medisch Centrum Heerlen | Heerlen | 6419 PC | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 CE | Netherlands |
| Sint-Elisabeth Ziekenhuis | Tilburg | 5022 GC | Netherlands |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Waikato District Health Board | Hamilton | 3240 | New Zealand |
| Helse Bergen HF - Haukeland Universitetssjukehus | Bergen | 5021 | Norway |
| Oslo Universitetssykehus-Rikshospitalet | Oslo | 0027 | Norway |
| Universitetssykehuset Nord-Norge | Tromsø | 9019 | Norway |
| Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie | Szczecin | 70-111 | Poland |
| Szpital Bielanski | Warsaw | 01-809 | Poland |
| Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE | Lisbon | 1649-035 | Portugal |
| Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH) | Bratislava | 83348 | Slovakia |
| Life Healthcare - Life Kingsbury Hospital | Cape Town | 7700 | South Africa |
| Life Healthcare - Life St Georges Hospital | Port Elizabeth | 6001 | South Africa |
| Netcare Unitas Hospital | Pretoria | 0157 | South Africa |
| Chonnam National University Hospital | Gwangju | 102-602 | South Korea |
| Yonsei University health System -Severence Hospital | Seoul | 120-752 | South Korea |
| Hospital Universitari Clínic de Barcelona | Barcelona | 08036 | Spain |
| Complejo Hospitalario Universitario Granada Hospital Campus de la Salud | Granada | 18016 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47006 | Spain |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 413 45 | Sweden |
| Universitetssjukhuset Örebro | Örebro | 701 85 | Sweden |
| Södersjukhuset | Stockholm | 118 83 | Sweden |
| Inselspital - Universitätsspital Bern | Bern | 3010 | Switzerland |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi | Istanbul | 34093 | Turkey (Türkiye) |
| Memorial Sisli Hastanesi | Istanbul | 34385 | Turkey (Türkiye) |
| Dokuz Eylül University | Izmir | 35220 | Turkey (Türkiye) |
| Adana Baskent University Hospital | Yüreğir | 01250 | Turkey (Türkiye) |
| Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| St George's University Hospitals - NHS Trust | London | SW17 0QT | United Kingdom |
| Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Institucion Medica Uruguaya | Montevideo | Uruguay |
| 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. |
| 22440235 | 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. |
| 23266281 | 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. |
| 22459746 | 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. |
| 23581758 | 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. |
| 24657065 | 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. |
| 25282698 | 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. |
| 25656594 | 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. |
| 31443976 | Derived | 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. |
| 27170150 | 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. |
| 25937606 | 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. |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided