Multiple PathologiesGREATNCT01658787

Global Registry for Endovascular Aortic Treatment (GREAT)

An observational study of Multiple Pathologies, run by W.L.Gore & Associates at 6 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

Prospective, observational Registry to obtain data on device performance and clinical outcomes. Read more about this study

Who is it for?: Any age
Conditions the study is for: Multiple Pathologies
What is being tested?: Endovascular aortic repair
Type of treatment: Medical device
How many people: 4,600 participants
Where: 6 sitesin 4 countries
Study dates: Dec 2010to Jun 2027
How long will I take part?: 10 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Consecutive series of patients who undergo treatment with Gore endovascular aortic products.

Who may be able to join

Minimum age required by state regulations
Indication for aortic endovascular stent graft repair
Signed informed consent

Who cannot join

Trial locations and contacts

6 sites in 4 countries.

Country

City, postcode or hospital

6 sites in 4 countries

United States2 sites

The University of Chicago Medicine & Biological Sciences
Chicago, Illinois, 60637
Baylor Research Institute
Plano, Texas

Other trials in United States

Italy2 sites

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
IRCCS Policlinico San Donato
Milan

Other trials in Italy

Australia1 site

Royal Prince Alfred Hospital
Camperdown, New South Wales

Other trials in Australia

Brazil1 site

Coris Medicina Avançada
Florianópolis

Other trials in Brazil

About this study

Official title: 'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation

Prospective, observational Registry to obtain data on device performance and clinical outcomes.

Read the 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.

Conditions: Multiple Pathologies
Being tested: Endovascular aortic repair
Keywords: Aorta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endovascular aortic repairDevice
Treatment with Gore Endovascular Aortic Products.

Study groups in NCT01658787
Study group	Role	What they receive
Endovascular aortic repair		Patients treated with Gore Endovascular Aortic Products. Receives: Device: Endovascular aortic repair

What is being measured

The primary outcome is the main question the study is designed to answer.

To collect "real world" data on the incidence of serious device events.
Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Jun 2027

First posted7 Aug 2012 (estimated)
Study startDec 2010
Primary completionJun 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Multiple PathologiesStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 4,600 participants (actual)
Target duration: 10 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT01658787
Sponsor's protocol ID: GRT 10-11
Acronym: GREAT
Status last verified: Feb 2026
First submitted: 3 Aug 2012
Last updated: 9 Feb 2026
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Allievi S, Mandigers TJ, Weaver FA, Azizzadeh A, Piffaretti G, Schermerhorn ML, Magee GA, Gable DR, Lomazzi C, Trimarchi S. Outcomes following extended thoracic endovascular aortic repair for Type B aortic dissection from the global registry for endovascular aortic treatment. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf156. doi: 10.1093/icvts/ivaf156.
PubMed 40674576
Payne D, Bockler D, Weaver F, Milner R, Magee GA, Azizzadeh A, Trimarchi S, Gable D; GREAT Investigators. Five-year outcomes of endovascular treatment for aortic dissection from the Global Registry for Endovascular Aortic Treatment. J Vasc Surg. 2024 Oct;80(4):1035-1044. doi: 10.1016/j.jvs.2024.05.055. Epub 2024 May 31.
PubMed 38825212
Gable DR, Verhoeven E, Trimarchi S, Bockler D, Milner R, Dubenec S, Silveira P, Weaver F; GREAT Investigators. Endovascular treatment for thoracic aortic disease from the Global Registry for Endovascular Aortic Treatment. J Vasc Surg. 2024 May;79(5):1044-1056.e1. doi: 10.1016/j.jvs.2023.12.040. Epub 2023 Dec 26.
PubMed 38154605
Ribieras AJ, Challa AS, Kang N, Kenel-Pierre S, Rey J, Velazquez OC, Milner R, Bornak A. Race-based outcomes of thoracic aortic aneurysms and dissections in the Global Registry for Endovascular Aortic Treatment. J Vasc Surg. 2023 Nov;78(5):1190-1197.e2. doi: 10.1016/j.jvs.2023.07.004. Epub 2023 Jul 16.
PubMed 37454953
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.
PubMed 34392333
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.
PubMed 32603847
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.
PubMed 31126763
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.
PubMed 29803683
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.
PubMed 29802041

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation
ClinicalTrials.gov ID: NCT01658787
Acronym / sponsor ID: GREAT / GRT 10-11
Conditions: Multiple Pathologies
Keywords: Aorta
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 4,600 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Dec 2010 (actual)
Primary completion: Jun 2027 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 7 Aug 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, observational Registry to obtain data on device performance and clinical outcomes.

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 design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 10 Years
Number of arms: 1

Arm	Type	Receives
Endovascular aortic repair	–	Device: Endovascular aortic repairPatients treated with Gore Endovascular Aortic Products.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Consecutive series of patients who undergo treatment with Gore endovascular aortic products.

Key inclusion criteria (3 listed)

Minimum age required by state regulations
Indication for aortic endovascular stent graft repair
Signed informed consent

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endovascular aortic repairTreatment with Gore Endovascular Aortic Products.	Device	Endovascular aortic repair

Primary outcome

To collect "real world" data on the incidence of serious device events.
Time frame: Up to 10 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Derived from this study: PubMed 40674576Allievi S, Mandigers TJ, Weaver FA, Azizzadeh A, Piffaretti G, Schermerhorn ML, Magee GA, Gable DR, Lomazzi C, Trimarchi S. Outcomes following extended thoracic endovascular aortic repair for Type B aortic dissection from the global registry for endovascular aortic treatment. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf156. doi: 10.1093/icvts/ivaf156.
Derived from this study: PubMed 38825212Payne D, Bockler D, Weaver F, Milner R, Magee GA, Azizzadeh A, Trimarchi S, Gable D; GREAT Investigators. Five-year outcomes of endovascular treatment for aortic dissection from the Global Registry for Endovascular Aortic Treatment. J Vasc Surg. 2024 Oct;80(4):1035-1044. doi: 10.1016/j.jvs.2024.05.055. Epub 2024 May 31.
Derived from this study: PubMed 38154605Gable DR, Verhoeven E, Trimarchi S, Bockler D, Milner R, Dubenec S, Silveira P, Weaver F; GREAT Investigators. Endovascular treatment for thoracic aortic disease from the Global Registry for Endovascular Aortic Treatment. J Vasc Surg. 2024 May;79(5):1044-1056.e1. doi: 10.1016/j.jvs.2023.12.040. Epub 2023 Dec 26.
Derived from this study: PubMed 37454953Ribieras AJ, Challa AS, Kang N, Kenel-Pierre S, Rey J, Velazquez OC, Milner R, Bornak A. Race-based outcomes of thoracic aortic aneurysms and dissections in the Global Registry for Endovascular Aortic Treatment. J Vasc Surg. 2023 Nov;78(5):1190-1197.e2. doi: 10.1016/j.jvs.2023.07.004. Epub 2023 Jul 16.
Derived from this study: PubMed 34392333Grassi 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.
Derived from this study: PubMed 32603847Baxter 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.
Derived from this study: PubMed 31126763Piffaretti 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.
Derived from this study: PubMed 29803683Shutze 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.
Derived from this study: PubMed 29802041Briggs 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ross Milner, MD, FACS principal investigator

The University of Chicago Medicine & Biological Sciences

Dennis Gable, MD principal investigator

Baylor Research Institute

Pierre Galvagni Silveira, MD, PhD principal investigator

Coris Medicina Avançada

6 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Pathologies, run by W.L.Gore & Associates at 6 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Italy, Australia, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To collect "real world" data on the incidence of serious device events. (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01658787, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.