- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01658787
Global Registry for Endovascular Aortic Treatment (GREAT) (GREAT)
February 5, 2026 updated by: W.L.Gore & Associates
'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation
Prospective, observational Registry to obtain data on device performance and clinical outcomes.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a prospective observational cohort Registry designed to obtain data on device performance and clinical outcomes of patients treated with Gore Endovascular Aortic products.
Study Type
Observational
Enrollment (Actual)
4600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New South Wales
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Camperdown, New South Wales, Australia
- Royal Prince Alfred Hospital
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-
-
-
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Florianópolis, Brazil
- Coris Medicina Avançada
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-
-
-
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Milan, Italy
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Milan, Italy
- IRCCS Policlinico San Donato
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Illinois
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Chicago, Illinois, United States, 60637
- The University of Chicago Medicine & Biological Sciences
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Texas
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Plano, Texas, United States
- Baylor Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Consecutive series of patients who undergo treatment with Gore endovascular aortic products.
Description
Inclusion Criteria:
- Minimum age required by state regulations
- Indication for aortic endovascular stent graft repair
- Signed informed consent
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Endovascular aortic repair
Patients treated with Gore Endovascular Aortic Products.
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Treatment with Gore Endovascular Aortic Products.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To collect "real world" data on the incidence of serious device events.
Time Frame: Up to 10 years
|
Up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dennis Gable, MD, Baylor Research Institute
- Principal Investigator: Ross Milner, MD, FACS, The University of Chicago Medicine & Biological Sciences
- Principal Investigator: Pierre Galvagni Silveira, MD, PhD, Coris Medicina Avançada
- Principal Investigator: Steven R Dubenec, MD, Royal Prince Alfred Hospital, Sydney, Australia
- Principal Investigator: Santi Trimarchi, MD, IRCCS Policlinico S. Donato
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Grassi V, Trimarchi S, Weaver F, de Beaufort HWL, Azzizzadeh A, Upchurch GR Jr, Piffaretti G, Lomazzi C; GREAT participants. Endovascular repair of descending thoracic aortic aneurysms-a mid-term report from the Global Registry for Endovascular Aortic Treatment (GREAT). Eur J Cardiothorac Surg. 2022 Jan 24;61(2):357-364. doi: 10.1093/ejcts/ezab366.
- Baxter RD, Hansen SK, Gable CE, DiMaio JM, Shutze WP, Gable DR; GREAT Investigators. Outcomes of Open Versus Percutaneous Access for Patients Enrolled in the GREAT Registry. Ann Vasc Surg. 2021 Jan;70:370-377. doi: 10.1016/j.avsg.2020.06.033. Epub 2020 Jun 27.
- Piffaretti G, Grassi V, Lomazzi C, Brinkman WT, Navarro TP, Jenkins MP, Trimarchi S; GREAT participants. Thoracic endovascular stent graft repair for ascending aortic diseases. J Vasc Surg. 2019 Nov;70(5):1384-1389.e1. doi: 10.1016/j.jvs.2019.01.075. Epub 2019 May 21.
- Shutze W, Suominen V, Jordan W, Cao P, Oweida S, Milner R. The incidence and effect of noncylindrical neck morphology on outcomes after endovascular aortic aneurysm repair in the Global Registry for Endovascular Aortic Treatment. J Vasc Surg. 2018 Dec;68(6):1714-1724. doi: 10.1016/j.jvs.2018.03.394. Epub 2018 May 24.
- Briggs C, Babrowski T, Skelly C, Milner R. Anatomic and clinical characterization of the narrow distal aorta and implications after endovascular aneurysm repair. J Vasc Surg. 2018 Oct;68(4):1030-1038.e1. doi: 10.1016/j.jvs.2017.12.073. Epub 2018 May 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2010
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
August 3, 2012
First Submitted That Met QC Criteria
August 3, 2012
First Posted (Estimated)
August 7, 2012
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRT 10-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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