GREAT Outcomes Evaluation

This study is currently recruiting participants.
Verified October 2013 by W.L.Gore & Associates
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01658787
First received: August 3, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Aortic Treatment
Device: Endovascular aortic repair

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: 'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • To collect "real world" data on the incidence of serious device events. [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: December 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aortic Pathologies
Patients treated with Gore Endovascular Aortic Products.
Device: Endovascular aortic repair

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658787

Contacts
Contact: Karen I Parsons 928-864-4256 kparsons@wlgore.com
Contact: Jay Donosky 928-864-3763 jdonosky@wlgore.com

Locations
United States, California
USC Cardiovascular Thoracic Institute Recruiting
Los Angeles, California, United States
Contact: Fred A Weaver, MD, MMM         
Principal Investigator: Fred A Weaver, MD, MMM         
United States, Illinois
The University of Chicago Medicine & Biological Sciences Recruiting
Chicago, Illinois, United States
Contact: Christopher Skelly, MD         
Principal Investigator: Christopher Skelly, MD         
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia
Principal Investigator: Steven R Dubenec, MD         
Brazil
Coris Medicina Avançada Recruiting
Florianópolis, Brazil
Principal Investigator: Pierre Galvagni Silveira, MD, PhD         
Italy
IRCCS Policlinico San Donato Recruiting
Milano, Italy
Contact: Santi Trimarchi, MD         
Principal Investigator: Santi Trimarchi, MD         
Azienda Ospedaliera San Camillo Forlanini Recruiting
Roma, Italy
Contact: Piergiorgio Cao, MD, FRCS         
Principal Investigator: Piergiorgio Cao, MD, FRCS         
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Ross Milner, MD, FACS The University of Chicago Medicine & Biological Sciences
Principal Investigator: Fred A Weaver, MD, MMM USC Cardiovascular Thoracic 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: Piergiorgio Cao, MD, FRCS Azienda Ospedaliera San Camillo Forlanini
Principal Investigator: Santi Trimarchi, MD IRCCS Policlinico San Donato
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01658787     History of Changes
Other Study ID Numbers: GRT 10-11
Study First Received: August 3, 2012
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014