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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00870051
Registration number
NCT00870051
Ethics application status
Date submitted
25/03/2009
Date registered
26/03/2009
Titles & IDs
Public title
Endurant Stent Graft Natural Selection Global Postmarket Registry
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Scientific title
Endurant Stent Graft Natural Selection Global Postmarket Registry
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Secondary ID [1]
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P#888
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Universal Trial Number (UTN)
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Trial acronym
ENGAGE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Aneurysm, Abdominal
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Endurant Stent Graft
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
Treatment: Devices: Endurant Stent Graft
Endurant Stent Graft implantation
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment Success
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Assessment method [1]
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Timepoint [1]
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10 years
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Secondary outcome [1]
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Stent Graft Migration
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Assessment method [1]
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Timepoint [1]
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10 years
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Secondary outcome [2]
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Stent Graft Patency
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Assessment method [2]
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Timepoint [2]
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10 years
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Secondary outcome [3]
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Stent Graft Endoleaks
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Assessment method [3]
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Timepoint [3]
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10 years
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Secondary outcome [4]
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Secondary procedures to correct Type I and III endoleaks
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Assessment method [4]
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Timepoint [4]
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10 years
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Secondary outcome [5]
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Secondary endovascular procedure
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Assessment method [5]
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0
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Timepoint [5]
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10 years
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Secondary outcome [6]
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Adverse Device Effects
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Assessment method [6]
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0
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Timepoint [6]
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10 years
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Secondary outcome [7]
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Technical Observations
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Assessment method [7]
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Timepoint [7]
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5 years
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Secondary outcome [8]
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Aneurysm-related mortality
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Assessment method [8]
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Timepoint [8]
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10 years
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Secondary outcome [9]
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All-cause mortality
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Assessment method [9]
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Timepoint [9]
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10 years
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Secondary outcome [10]
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MAE
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Assessment method [10]
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Timepoint [10]
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30 days
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Secondary outcome [11]
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Health Related Quality of Life Scores
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Assessment method [11]
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Timepoint [11]
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12 months
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Secondary outcome [12]
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Stent Graft Stenosis
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Assessment method [12]
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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.
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Timepoint [12]
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10 years
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Secondary outcome [13]
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AAA Diameter Increase
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Assessment method [13]
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Timepoint [13]
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10 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* High probability of non-adherence to physician's follow-up requirements
* Current participation in a concurrent trial which may confound study results
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/04/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/09/2021
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Sample size
Target
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Accrual to date
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Final
1266
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Royal Brisbane and Women's Hospital - Brisbane
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St Andrew's Hospital - Adelaide
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The Queen Elizabeth Hospital - Adelaide
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Box Hill Hospital - Melbourne
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Recruitment hospital [6]
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Epworth Healthcare - Epworth Eastern - Melbourne
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Recruitment hospital [7]
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JMLS Medical Services PTY, trading as Perth Institute of Vascular Research - Nedlands
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Recruitment hospital [8]
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Royal Perth Hospital - Perth
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Recruitment hospital [9]
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Hollywood Private Hospital - Perth
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4029 - Brisbane
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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5011 - Adelaide
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Recruitment postcode(s) [5]
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3128 - Melbourne
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment postcode(s) [7]
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6001 - Perth
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Recruitment postcode(s) [8]
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6009 - Perth
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Austria
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Wien
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Bonheiden
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Belgium
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Dendermonde
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Belgium
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Edegem
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Belgium
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Gent
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Halifax
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Canada
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London
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Canada
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Montréal
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Canada
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Québec
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Canada
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Toronto
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China
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Beijing
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China
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Chengdu
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China
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Guangzhou
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Praha
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Bordeaux
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Créteil
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France
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Pessac
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Heidelberg
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Germany
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Münster
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Germany
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Solingen
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Tel Aviv
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Bologna
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Italy
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Firenze
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Italy
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Siena
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Gwangju
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Heerlen
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Hamilton
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Bergen
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Oslo
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Bratislava
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Cape Town
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Port Elizabeth
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Pretoria
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Spain
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Barcelona
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Spain
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Spain
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Spain
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Örebro
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Bern
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Thailand
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Songkhla
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Yüregir
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United Kingdom
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Cambridge
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyne
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Uruguay
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Montevideo
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic Cardiovascular
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.
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Trial website
https://clinicaltrials.gov/study/NCT00870051
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Trial related presentations / 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. 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. 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. 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. 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. 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. 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. 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. Erratum In: J Vasc Surg. 2015 Jan;61(1):285. Boeckler, Dittmar [Corrected to Bockler, Dittmar]. 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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Vicente Riambau, Prof.
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Address
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Hospital Clinic of Barcelona
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Fax
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Only multi center data will be available
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Bockler D, Fitridge R, Wolf Y, Hayes P, Silveira P...
[
More Details
]
Journal
Stokmans RA, Teijink JA, Forbes TL, Bockler D, Pee...
[
More Details
]
Journal
Stokmans RA, Teijink JA, Cuypers PW, Riambau V, va...
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Journal
Dubois L, Novick TV, Harris JR, Derose G, Forbes T...
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]
Journal
Pol RA, Zeebregts CJ, van Sterkenburg SM, Reijnen ...
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Journal
Tang T, Sadat U, Walsh S, Hayes PD; ENGAGE Investi...
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Journal
Pol RA, Zeebregts CJ, van Sterkenburg SM, Ferreira...
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Journal
Kiguchi MM, Forbes TL, Teijink JA, Pliagas GA, Ell...
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]
Journal
Faure EM, Becquemin JP, Cochennec F; ENGAGE collab...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00870051