Clinical trial NCT01658787: Global Registry for Endovascular Aortic Treatment (GREAT)
Official title: 'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Pathologies
Keywords: Aorta
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2012-08-07
Enrollment: 4600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive series of patients who undergo treatment with Gore endovascular aortic products.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: To collect "real world" data on the incidence of serious device events.
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medicine & Biological Sciences
state: Illinois
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Florianópolis
country: Brazil
facility: Coris Medicina Avançada
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Policlinico San Donato
Study officials:
affiliation: The University of Chicago Medicine & Biological Sciences
name: Ross Milner, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor Research Institute
name: Dennis Gable, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Coris Medicina Avançada
name: Pierre Galvagni Silveira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Steven R Dubenec, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Policlinico S. Donato
name: Santi Trimarchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.