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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
Scientific title
Endurant Stent Graft Natural Selection Global Postmarket Registry
Secondary ID [1] 0 0
P#888
Universal Trial Number (UTN)
Trial acronym
ENGAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Aneurysm, Abdominal 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Success
Timepoint [1] 0 0
10 years
Secondary outcome [1] 0 0
Stent Graft Migration
Timepoint [1] 0 0
10 years
Secondary outcome [2] 0 0
Stent Graft Patency
Timepoint [2] 0 0
10 years
Secondary outcome [3] 0 0
Stent Graft Endoleaks
Timepoint [3] 0 0
10 years
Secondary outcome [4] 0 0
Secondary procedures to correct Type I and III endoleaks
Timepoint [4] 0 0
10 years
Secondary outcome [5] 0 0
Secondary endovascular procedure
Timepoint [5] 0 0
10 years
Secondary outcome [6] 0 0
Adverse Device Effects
Timepoint [6] 0 0
10 years
Secondary outcome [7] 0 0
Technical Observations
Timepoint [7] 0 0
5 years
Secondary outcome [8] 0 0
Aneurysm-related mortality
Timepoint [8] 0 0
10 years
Secondary outcome [9] 0 0
All-cause mortality
Timepoint [9] 0 0
10 years
Secondary outcome [10] 0 0
MAE
Timepoint [10] 0 0
30 days
Secondary outcome [11] 0 0
Health Related Quality of Life Scores
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Stent Graft Stenosis
Timepoint [12] 0 0
10 years
Secondary outcome [13] 0 0
AAA Diameter Increase
Timepoint [13] 0 0
10 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/09/2021
Sample size
Target
Accrual to date
Final
1266
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
St Andrew's Hospital - Adelaide
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [5] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [6] 0 0
Epworth Healthcare - Epworth Eastern - Melbourne
Recruitment hospital [7] 0 0
JMLS Medical Services PTY, trading as Perth Institute of Vascular Research - Nedlands
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [9] 0 0
Hollywood Private Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6001 - Perth
Recruitment postcode(s) [8] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Bonheiden
Country [4] 0 0
Belgium
State/province [4] 0 0
Dendermonde
Country [5] 0 0
Belgium
State/province [5] 0 0
Edegem
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Canada
State/province [7] 0 0
Halifax
Country [8] 0 0
Canada
State/province [8] 0 0
London
Country [9] 0 0
Canada
State/province [9] 0 0
Montréal
Country [10] 0 0
Canada
State/province [10] 0 0
Québec
Country [11] 0 0
Canada
State/province [11] 0 0
Toronto
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Chengdu
Country [14] 0 0
China
State/province [14] 0 0
Guangzhou
Country [15] 0 0
Colombia
State/province [15] 0 0
Bogotá
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha
Country [17] 0 0
France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
France
State/province [18] 0 0
Créteil
Country [19] 0 0
France
State/province [19] 0 0
Pessac
Country [20] 0 0
Germany
State/province [20] 0 0
Heidelberg
Country [21] 0 0
Germany
State/province [21] 0 0
Münster
Country [22] 0 0
Germany
State/province [22] 0 0
Solingen
Country [23] 0 0
Greece
State/province [23] 0 0
Thessaloníki
Country [24] 0 0
Hong Kong
State/province [24] 0 0
Hong Kong
Country [25] 0 0
Israel
State/province [25] 0 0
Tel Aviv
Country [26] 0 0
Italy
State/province [26] 0 0
Bologna
Country [27] 0 0
Italy
State/province [27] 0 0
Firenze
Country [28] 0 0
Italy
State/province [28] 0 0
Siena
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Gwangju
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul
Country [31] 0 0
Lithuania
State/province [31] 0 0
Vilnius
Country [32] 0 0
Netherlands
State/province [32] 0 0
Arnhem
Country [33] 0 0
Netherlands
State/province [33] 0 0
Eindhoven
Country [34] 0 0
Netherlands
State/province [34] 0 0
Heerlen
Country [35] 0 0
Netherlands
State/province [35] 0 0
Nieuwegein
Country [36] 0 0
Netherlands
State/province [36] 0 0
Rotterdam
Country [37] 0 0
Netherlands
State/province [37] 0 0
Tilburg
Country [38] 0 0
New Zealand
State/province [38] 0 0
Auckland
Country [39] 0 0
New Zealand
State/province [39] 0 0
Hamilton
Country [40] 0 0
Norway
State/province [40] 0 0
Bergen
Country [41] 0 0
Norway
State/province [41] 0 0
Oslo
Country [42] 0 0
Norway
State/province [42] 0 0
Tromsø
Country [43] 0 0
Poland
State/province [43] 0 0
Szczecin
Country [44] 0 0
Poland
State/province [44] 0 0
Warszawa
Country [45] 0 0
Portugal
State/province [45] 0 0
Lisboa
Country [46] 0 0
Slovakia
State/province [46] 0 0
Bratislava
Country [47] 0 0
South Africa
State/province [47] 0 0
Cape Town
Country [48] 0 0
South Africa
State/province [48] 0 0
Port Elizabeth
Country [49] 0 0
South Africa
State/province [49] 0 0
Pretoria
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Granada
Country [52] 0 0
Spain
State/province [52] 0 0
Oviedo
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia
Country [54] 0 0
Spain
State/province [54] 0 0
Valladolid
Country [55] 0 0
Sweden
State/province [55] 0 0
Göteborg
Country [56] 0 0
Sweden
State/province [56] 0 0
Stockholm
Country [57] 0 0
Sweden
State/province [57] 0 0
Örebro
Country [58] 0 0
Switzerland
State/province [58] 0 0
Bern
Country [59] 0 0
Thailand
State/province [59] 0 0
Songkhla
Country [60] 0 0
Turkey
State/province [60] 0 0
Istanbul
Country [61] 0 0
Turkey
State/province [61] 0 0
Izmir
Country [62] 0 0
Turkey
State/province [62] 0 0
Yüregir
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Cambridge
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Liverpool
Country [65] 0 0
United Kingdom
State/province [65] 0 0
London
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Manchester
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Newcastle Upon Tyne
Country [68] 0 0
Uruguay
State/province [68] 0 0
Montevideo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vicente Riambau, Prof.
Address 0 0
Hospital Clinic of Barcelona
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only multi center data will be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT00870051