title: The Gore Global Registry for Endovascular Aortic Treatment: Objectives and Design.
abstract: BACKGROUND
  The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective observational multicenter cohort registry that was initiated in November 2011. The aim of the GREAT is to collect contemporary real-world data on the performance of all Gore aortic endografts in the treatment of multiple aortic pathologies. The primary and secondary objectives, design, and future directions of the GREAT are described.
  
  
  METHODS
  The GREAT aims to enroll 5000 consecutive patients with Gore thoracic and abdominal aortic endografts from multiple centers throughout the world. The GREAT has broad inclusion criteria with minimal exclusion criteria to reflect real-world practice such as including off-label use, nonstandard indications and devices deployed outside instruction for use. Follow-up will extend to 10 years providing major insights into the long-term durability and behavior of Gore aortic endografts. Primary end points include the incidence and timing of (1) endoleak of any type, (2) endograft migration and/or stent fracture, (3) endograft explantation, and (4) aortic rupture. Secondary end points include the following: (1) incidence of serious device events by pathology, (2) incidence of serious device events by aortic segment (ascending aorta, arch of aorta, descending thoracic aorta, abdominal aorta), (3) long-term survival by pathology, and (4) aorta-related mortality by pathology.
  
  
  RESULTS
  As of June 2015, 2960 patients have been enrolled into the GREAT from 78 centers in Europe, the United States, Australia, New Zealand, and Brazil. The majority of patients and centers are from Europe and the United States. Completion of enrollment is anticipated to be in 2017 with interim results planned to be published during enrollment and on follow-up.
  
  
  CONCLUSIONS
  Upon completion, the GREAT will be among the largest clinical registry to date of abdominal and thoracic aortic devices manufactured by a single sponsor. It will provide valuable real-world data on the use and durability of Gore aortic endografts in the treatment of a variety of aortic pathologies and devices deployed within and outside instruction for use.
authors.affiliation: Department of Vascular Surgery, Royal Prince Alfred Hospital, Sydney, NSW, Australia. Electronic address: jackyloa@hotmail.com.
authors.forename: Jacky
authors.initials: J
authors.lastname: Loa
authors.affiliation: Department of Vascular Surgery, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
authors.forename: Steven
authors.initials: S
authors.lastname: Dubenec
authors.affiliation: Division of Vascular Surgery, Azienda Ospedaliera San Camillo Forlanini, Roma, Italy.
authors.forename: Piergiorgio
authors.initials: P
authors.lastname: Cao
authors.affiliation: Department of Surgery, University of Chicago Medical Center, Chicago, IL.
authors.forename: Ross
authors.initials: R
authors.lastname: Milner
authors.affiliation: Department of Vascular Service and Surgery, Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, Brazil.
authors.forename: Pierre G
authors.initials: PG
authors.lastname: Silveira
authors.affiliation: Cardiovascular Department, IRCCS Policlinico San Donato, Milan, Italy.
authors.forename: Santi
authors.initials: S
authors.lastname: Trimarchi
authors.affiliation: Department of Vascular and Endovacular Surgery, Paracelsus Medical University Nuernberg, Nuernberg, Germany.
authors.forename: Eric
authors.initials: E
authors.lastname: Verhoeven
authors.affiliation: Division of Vascular Surgery, Department of Surgery, University of Southern California, Los Angeles, CA.
authors.forename: Fred
authors.initials: F
authors.lastname: Weaver
mesh_terms: D001012:Aorta, Abdominal / Q000601:surgery*; D001013:Aorta, Thoracic / Q000601:surgery*; D001018:Aortic Diseases / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D006040:Goals; D006801:Humans; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012107:Research Design; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome