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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/NCT01658787




Registration number
NCT01658787
Ethics application status
Date submitted
3/08/2012
Date registered
7/08/2012
Date last updated
8/05/2024

Titles & IDs
Public title
Global Registry for Endovascular Aortic Treatment (GREAT)
Scientific title
'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation
Secondary ID [1] 0 0
GRT 10-11
Universal Trial Number (UTN)
Trial acronym
GREAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Pathologies 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Endovascular aortic repair

Endovascular aortic repair - Patients treated with Gore Endovascular Aortic Products.


Treatment: Devices: Endovascular aortic repair
Treatment with Gore Endovascular Aortic Products.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To collect "real world" data on the incidence of serious device events.
Timepoint [1] 0 0
Up to 10 years

Eligibility
Key inclusion criteria
- Minimum age required by state regulations

- Indication for aortic endovascular stent graft repair

- Signed informed consent
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- N/A

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
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
Accrual to date
Final
4600
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Brazil
State/province [3] 0 0
Florianópolis
Country [4] 0 0
Italy
State/province [4] 0 0
Milano

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
W.L.Gore & Associates
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective, observational Registry to obtain data on device performance and clinical
outcomes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01658787
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ross Milner, MD, FACS
Address 0 0
The University of Chicago Medicine & Biological Sciences
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01658787