NCT01658787

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,600

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
4 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Dec 2010Jun 2027

Study Start

First participant enrolled

December 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

16.5 years

First QC Date

August 3, 2012

Last Update Submit

February 5, 2026

Conditions

Multiple Pathologies

Keywords

Aorta

Outcome Measures

Primary Outcomes (1)

  • To collect "real world" data on the incidence of serious device events.

    Up to 10 years

Study Arms (1)

Endovascular aortic repair

Patients treated with Gore Endovascular Aortic Products.

Device: Endovascular aortic repair

Interventions

Endovascular aortic repairDEVICE

Treatment with Gore Endovascular Aortic Products.

Endovascular aortic repair

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The University of Chicago Medicine & Biological Sciences

Chicago, Illinois, 60637, United States

Location

Baylor Research Institute

Plano, Texas, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Location

Coris Medicina Avançada

Florianópolis, Brazil

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

IRCCS Policlinico San Donato

Milan, Italy

Location

Related Publications (5)

  • 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.

    PMID: 34392333DERIVED

  • 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.

    PMID: 32603847DERIVED

  • 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.

    PMID: 31126763DERIVED

  • 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.

    PMID: 29803683DERIVED

  • 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.

    PMID: 29802041DERIVED

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Officials

  • Ross Milner, MD, FACS

    The University of Chicago Medicine & Biological Sciences

    PRINCIPAL INVESTIGATOR

  • Dennis Gable, MD

    Baylor Research Institute

    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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 7, 2012

Study Start

December 1, 2010

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)AU(1)IT(2)BR(1)