Aortic Aneurysm, AbdominalENGAGENCT00870051
Endurant Stent Graft Natural Selection Global Postmarket Registry
An observational study of Aortic Aneurysm, Abdominal, run by Medtronic Cardiovascular at 80 sites in 30 countries.
Trial summary
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Endurant Stent Graft
- Type of treatment
- Medical device
- How many people
- 1,266 participants
- Where
- 80 sitesin 30 countries
- Study dates
- 8 Apr 2009to 23 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with an AAA who are considered candidates for endovascular
Who may be able to join
- 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.
Who cannot join
- High probability of non-adherence to physician's follow-up requirements
- Current participation in a concurrent trial which may confound study results
Trial locations and contacts
80 sites in 30 countries.
80 sites in 30 countries
Australia9 sites
St Andrew's Hospital
Adelaide, South Australia, 5000
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Box Hill Hospital
Melbourne, Victoria, 3128
Epworth Healthcare - Epworth Eastern
Melbourne, Victoria, 3128
JMLS Medical Services PTY, trading as Perth Institute of Vascular Research
Nedlands, Western Australia, 6009
Royal Perth Hospital
Perth, Western Australia, 6001
Hollywood Private Hospital
Perth, Western Australia, 6009
Netherlands6 sites
Rijnstate - Locatie Arnhem
Arnhem, 6815 AD
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Zuyderland Medisch Centrum Heerlen
Heerlen, 6419 PC
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Erasmus Medisch Centrum
Rotterdam, 3015 CE
Sint-Elisabeth Ziekenhuis
Tilburg, 5022 GC
Canada5 sites
Queen Elizabeth II Health Sciences Centre
Halifax, B3H 3A7
London Health Sciences Centre - Victoria Hospital
London, N6A 5W9
Glen Royal Victoria Hospital
Montreal, H4A 3J1
CHUQ - Hôpital Saint-François d'Assise
Québec, G1L 3L5
Toronto General Hospital
Toronto, M5G 2C4
Spain5 sites
Hospital Universitari Clínic de Barcelona
Barcelona, 08036
Complejo Hospitalario Universitario Granada Hospital Campus de la Salud
Granada, 18016
Hospital Universitario Central de Asturias
Oviedo, 33011
Hospital Universitario Dr. Peset
Valencia, 46017
Hospital Clínico Universitario de Valladolid
Valladolid, 47006
United Kingdom5 sites
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, CB2 0QQ
The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
Liverpool, L7 8XP
St George's University Hospitals - NHS Trust
London, SW17 0QT
Wythenshawe Hospital
Manchester, M23 9LT
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Belgium4 sites
Imeldaziekenhuis
Bonheiden, 2820
AZ Sint-Blasius-Campus Dendermonde
Dendermonde, 9200
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
Turkey (Türkiye)4 sites
Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi
Istanbul, 34093
Memorial Sisli Hastanesi
Istanbul, 34385
Dokuz Eylül University
Izmir, 35220
Adana Baskent University Hospital
Yüreğir, 01250
China3 sites
Chinese PLA General Hospital
Beijing, 100853
West China Hospital of Sichuan University
Chengdu, 610041
People's Hospital of Guangdong Province
Guangzhou, 510080
France3 sites
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux, 33000
Hôpitaux Universitaires - Hôpital Henri Mondor
Créteil, 94010
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, 33604
Germany3 sites
Universitätsklinikum Heidelberg
Heidelberg, 69120
St. Franziskus-Hospital Münster GmbH
Münster, 48145
Städtisches Klinikum Solingen
Solingen, 42653
Italy3 sites
Policlinico Sant' Orsola - Malpighi
Bologna, 40138
Azienda Ospedaliera-Universitaria Careggi
Florence, 50134
Azienda Ospedaliera Universitaria Senese
Siena, 53100
Norway3 sites
Helse Bergen HF - Haukeland Universitetssjukehus
Bergen, 5021
Oslo Universitetssykehus-Rikshospitalet
Oslo, 0027
Universitetssykehuset Nord-Norge
Tromsø, 9019
South Africa3 sites
Life Healthcare - Life Kingsbury Hospital
Cape Town, 7700
Life Healthcare - Life St Georges Hospital
Port Elizabeth, 6001
Netcare Unitas Hospital
Pretoria, 0157
Sweden3 sites
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Universitetssjukhuset Örebro
Örebro, 701 85
Södersjukhuset
Stockholm, 118 83
Argentina2 sites
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABD
Clínica La Sagrada Familia
Buenos Aires, C1426EOB
Greece2 sites
Euromedica - Kyanous Stavros General Hospital
Thessaloniki, 54636
Papageorgiou General Hospital
Thessaloniki, 56429
New Zealand2 sites
Auckland City Hospital
Auckland, 1023
Waikato District Health Board
Hamilton, 3240
Poland2 sites
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, 70-111
Szpital Bielanski
Warsaw, 01-809
South Korea2 sites
Chonnam National University Hospital
Gwangju, 102-602
Yonsei University health System -Severence Hospital
Seoul, 120-752
Czechia1 site
IKEM - Institutu Klinicke a Experimentalni Mediciny
Prague, 140 21
Lithuania1 site
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
Portugal1 site
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
Lisbon, 1649-035
Slovakia1 site
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
Bratislava, 83348
About this study
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.
Read the 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.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Endurant Stent Graft
- Keywords
- Endurant, Stent Graft, Abdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurant Stent GraftDevice
Also called EVAR
Endurant Stent Graft implantation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Endurant Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success
Measured: 10 years
Secondary outcomes (13)
Stent Graft Migration
Measured: 10 years
Stent Graft Patency
Measured: 10 years
Stent Graft Endoleaks
Measured: 10 years
Secondary procedures to correct Type I and III endoleaks
Measured: 10 years
Secondary endovascular procedure
Measured: 10 years
Adverse Device Effects
Measured: 10 years
Technical Observations
Measured: 5 years
Aneurysm-related mortality
Measured: 10 years
All-cause mortality
Measured: 10 years
MAE
Measured: 30 days
Health Related Quality of Life Scores
Measured: 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.
Measured: 10 years
AAA Diameter Increase
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study start8 Apr 2009
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicente Riambau, Prof., Study director, Hospital Clinic of BarcelonaFuruzan Numan, prof, Study director, Memorial Hospital IstanbulRobert A. Fitridge, Dr., Study director, The Queen Elizabeth Hospital, Woodville, South Adelaide, AustraliaYehuda Wolf, Prof., Study director, Tel Aviv Sourasky Medical Center, IsraelDittmar Böckler, Prof., Study director, Universtiy of Heidelberg, GermanyPaul Hayes, Dr., Study director, Addenbrookes Hospital, Cambridge, Great Britain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870051
- Sponsor's protocol ID
- P#888
- Acronym
- ENGAGE
- Status last verified
- Jan 2022
- First submitted
- 25 Mar 2009
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only multi center data will be available
Publications
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.
PubMed 20671632Stokmans 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.
PubMed 22835762Stokmans 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.
PubMed 22440235Dubois 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.
PubMed 23266281Pol 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.
PubMed 22459746Tang 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.
PubMed 23581758Pol 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.
PubMed 24657065Kiguchi 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.
PubMed 25282698Faure 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.
PubMed 25656594Dijkstra 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.
PubMed 31443976Dijkstra 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.
PubMed 27170150Broos 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.
PubMed 25937606
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endurant Stent Graft Natural Selection Global Postmarket Registry
- ClinicalTrials.gov ID
- NCT00870051
- Acronym / sponsor ID
- ENGAGE / P#888
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Endurant, Stent Graft, Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2009 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA patients | – | Device: Endurant Stent GraftSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with an AAA who are considered candidates for endovascular
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- High probability of non-adherence to physician's follow-up requirements
- Current participation in a concurrent trial which may confound study results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurant Stent GraftAlso: EVAREndurant Stent Graft implantation | Device | AAA patients |
Primary outcome
Treatment Success
Time frame: 10 years
13 secondary outcomes
Stent Graft Migration
Time frame: 10 years
Stent Graft Patency
Time frame: 10 years
Stent Graft Endoleaks
Time frame: 10 years
Secondary procedures to correct Type I and III endoleaks
Time frame: 10 years
Secondary endovascular procedure
Time frame: 10 years
Adverse Device Effects
Time frame: 10 years
Technical Observations
Time frame: 5 years
Aneurysm-related mortality
Time frame: 10 years
All-cause mortality
Time frame: 10 years
MAE
Time frame: 30 days
Health Related Quality of Life Scores
Time frame: 12 months
Stent Graft Stenosis
Time frame: 10 years
AAA Diameter Increase
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Results publication: PubMed 20671632Bockler 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.
- Results publication: PubMed 22835762Stokmans 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.
- Results publication: PubMed 22440235Stokmans 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.
- Results publication: PubMed 23266281Dubois 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.
- Results publication: PubMed 22459746Pol 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.
- Results publication: PubMed 23581758Tang 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.
- Results publication: PubMed 24657065Pol 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.
- Results publication: PubMed 25282698Kiguchi 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.
- Results publication: PubMed 25656594Faure 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.
- Derived from this study: PubMed 31443976Dijkstra 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.
- Derived from this study: PubMed 27170150Dijkstra 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.
- Derived from this study: PubMed 25937606Broos 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.
- Individual participant dataSharing planned: No. Only multi center data will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicente Riambau, Prof. study director
Hospital Clinic of Barcelona
Furuzan Numan, prof study director
Memorial Hospital Istanbul
Robert A. Fitridge, Dr. study director
The Queen Elizabeth Hospital, Woodville, South Adelaide, Australia
80 sites in 30 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal, run by Medtronic Cardiovascular at 80 sites in 30 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in Australia, Netherlands, Canada, Spain, United Kingdom and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870051, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.