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GREAT Outcomes Evaluation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 14, 2014
Last verified: July 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 14, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 27, 2014