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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00870051
Registration number
NCT00870051
Ethics application status
Date submitted
25/03/2009
Date registered
26/03/2009
Date last updated
9/02/2022
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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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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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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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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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [3]
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St Andrew's Hospital - Adelaide
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Recruitment hospital [4]
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The Queen Elizabeth Hospital - Adelaide
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Recruitment hospital [5]
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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
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Austria
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Wien
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Belgium
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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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Canada
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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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Colombia
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Bogotá
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Czechia
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Praha
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France
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Bordeaux
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France
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Créteil
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France
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Pessac
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Germany
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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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Greece
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Thessaloníki
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Hong Kong
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Hong Kong
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Israel
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Tel Aviv
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Italy
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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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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
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Lithuania
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Vilnius
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Arnhem
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Eindhoven
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Heerlen
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Nieuwegein
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Auckland
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Hamilton
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Tromsø
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Szczecin
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Poland
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Warszawa
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Lisboa
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Bratislava
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Cape Town
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Oviedo
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Spain
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Valladolid
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Stockholm
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Sweden
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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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State/province [67]
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Newcastle Upon Tyne
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Country [68]
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Uruguay
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State/province [68]
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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/ct2/show/NCT00870051
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Trial related presentations / publications
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00870051
Download to PDF