Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE)

January 26, 2022 updated by: Medtronic Cardiovascular
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABD
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1426EOB
        • Clinica La Sagrada Familia
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
      • Adelaide, South Australia, Australia, 5000
        • St Andrew's Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3128
        • Box Hill Hospital
      • Melbourne, Victoria, Australia, 3128
        • Epworth Healthcare - Epworth Eastern
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • JMLS Medical Services PTY, trading as Perth Institute of Vascular Research
      • Perth, Western Australia, Australia, 6001
        • Royal Perth Hospital
      • Perth, Western Australia, Australia, 6009
        • Hollywood Private Hospital
  • Austria
      • Wien, Austria, 1130
        • Krankenhaus Hietzing
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Dendermonde, Belgium, 9200
        • AZ Sint-Blasius-Campus Dendermonde
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
  • Canada
      • Halifax, Canada, B3H 3A7
        • Queen Elizabeth Ii Health Sciences Centre
      • London, Canada, N6A 5W9
        • London Health Sciences Centre - Victoria Hospital
      • Montréal, Canada, H4A 3J1
        • Glen Royal Victoria Hospital
      • Québec, Canada, G1L 3L5
        • CHUQ - Hôpital Saint-François d'Assise
      • Toronto, Canada, M5G 2C4
        • Toronto General Hospital
  • China
      • Beijing, China, 100853
        • Chinese PLA General Hospital
      • Chengdu, China, 610041
        • West China Hospital of Sichuan University
      • Guangzhou, China, 510080
        • People's Hospital of Guangdong Province
  • Colombia
      • Bogotá, Colombia
        • Fundacion Cardioinfantil
  • Czechia
      • Praha, Czechia, 140 21
        • IKEM - Institutu Klinicke a Experimentalni Mediciny
  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux - Centre Universitaire Pellegrin
      • Créteil, France, 94010
        • Hôpitaux Universitaires - Hôpital Henri Mondor
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque - CHU de Bordeaux
  • Germany
      • Heidelberg, Germany, 69120
        • Universitatsklinikum Heidelberg
      • Münster, Germany, 48145
        • St. Franziskus-Hospital Münster GmbH
      • Solingen, Germany, 42653
        • Städtisches Klinikum Solingen
  • Greece
      • Thessaloníki, Greece, 56429
        • Papageorgiou General Hospital
      • Thessaloníki, Greece, 54636
        • Euromedica - Kyanous Stavros General Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • Israel
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sant' Orsola - Malpighi
      • Firenze, Italy, 50134
        • Azienda Ospedaliera-Universitaria Careggi
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
  • Korea, Republic of
      • Gwangju, Korea, Republic of, 102-602
        • Chonnam National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University health System -Severence Hospital
  • Lithuania
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos
  • Netherlands
      • Arnhem, Netherlands, 6815 AD
        • Rijnstate - Locatie Arnhem
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Heerlen, Netherlands, 6419 PC
        • Zuyderland Medisch Centrum Heerlen
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medisch Centrum
      • Tilburg, Netherlands, 5022 GC
        • Sint-Elisabeth Ziekenhuis
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Hamilton, New Zealand, 3240
        • Waikato District Health Board
  • Norway
      • Bergen, Norway, 5021
        • Helse Bergen HF - Haukeland Universitetssjukehus
      • Oslo, Norway, 0027
        • Oslo Universitetssykehus-Rikshospitalet
      • Tromsø, Norway, 9019
        • Universitetssykehuset Nord-Norge
  • Poland
      • Szczecin, Poland, 70-111
        • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie
      • Warszawa, Poland, 01-809
        • Szpital Bielanski
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
  • Slovakia
      • Bratislava, Slovakia, 83348
        • Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
  • South Africa
      • Cape Town, South Africa, 7700
        • Life Healthcare - Life Kingsbury Hospital
      • Port Elizabeth, South Africa, 6001
        • Life Healthcare - Life St Georges Hospital
      • Pretoria, South Africa, 0157
        • Netcare Unitas Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Universitari Clínic de Barcelona
      • Granada, Spain, 18016
        • Complejo Hospitalario Universitario Granada Hospital Campus de la Salud
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
      • Valladolid, Spain, 47006
        • Hospital Clínico Universitario de Valladolid
  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
      • Stockholm, Sweden, 118 83
        • Södersjukhuset
      • Örebro, Sweden, 701 85
        • Universitetssjukhuset Orebro
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital - Universitätsspital Bern
  • Thailand
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi
      • Istanbul, Turkey, 34385
        • Memorial Şişli Hastanesi
      • Yüreğir, Turkey, 01250
        • Adana Baskent University Hospital
      • İzmir, Turkey, 35220
        • Dokuz Eylul University
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
      • Liverpool, United Kingdom, L7 8XP
        • The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals - NHS Trust
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
  • Uruguay
      • Montevideo, Uruguay
        • Institucion Medica Uruguaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed with an AAA who are considered candidates for endovascular

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Endurant Stent Graft implantation
Other Names:
  • EVAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment Success
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 10 years
10 years
Stent Graft Migration
Time Frame: 10 years
10 years
Stent Graft Patency
Time Frame: 10 years
10 years
Stent Graft Endoleaks
Time Frame: 10 years
10 years
Secondary procedures to correct Type I and III endoleaks
Time Frame: 10 years
10 years
Secondary endovascular procedure
Time Frame: 10 years
10 years
Adverse Device Effects
Time Frame: 10 years
10 years
Technical Observations
Time Frame: 5 years
5 years
Aneurysm-related mortality
Time Frame: 10 years
10 years
MAE
Time Frame: 30 days
30 days
Health Related Quality of Life Scores
Time Frame: 12 months
12 months
Stent Graft Stenosis
Time Frame: 10 years
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
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 8, 2009

Primary Completion (ACTUAL)

September 23, 2021

Study Completion (ACTUAL)

September 23, 2021

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (ESTIMATE)

March 26, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P#888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only multi center data will be available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe