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Global Registry for Endovascular Aortic Treatment (GREAT) (GREAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01658787
First received: August 3, 2012
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
Prospective, observational Registry to obtain data on device performance and clinical outcomes.

Condition Intervention
Multiple Pathologies
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 ]

Enrollment: 4625
Study Start Date: December 2010
Estimated Study Completion Date: September 2026
Estimated Primary Completion Date: September 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Endovascular aortic repair
Patients treated with Gore Endovascular Aortic Products.
Device: Endovascular aortic repair
Treatment with Gore Endovascular Aortic Products.

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

Ages Eligible for Study:   Child, Adult, Senior
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:

  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

Locations
United States, California
USC Cardiovascular Thoracic Institute
Los Angeles, California, United States, 90033
United States, Illinois
The University of Chicago Medicine & Biological Sciences
Chicago, Illinois, United States, 60637
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Brazil
Coris Medicina Avançada
Florianópolis, Brazil
Italy
IRCCS Policlinico San Donato
Milano, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy
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

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 27, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by W.L.Gore & Associates:
Aorta

ClinicalTrials.gov processed this record on December 07, 2016