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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00870051




Registration number
NCT00870051
Ethics application status
Date submitted
25/03/2009
Date registered
25/03/2009
Date last updated
28/01/2019

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 - 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.
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
SA 5011 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Endovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant
Stent Graft System from AAA subjects.
Trial website
https://clinicaltrials.gov/show/NCT00870051
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

Summary results
Other publications