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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01658787
Recruitment Status : Active, not recruiting
First Posted : August 7, 2012
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Prospective, observational Registry to obtain data on device performance and clinical outcomes.

Condition or disease Intervention/treatment
Multiple Pathologies Device: Endovascular aortic repair

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.

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 4625 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: 'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation
Study Start Date : December 2010
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026
Groups and Cohorts

Group/Cohort Intervention/treatment
Endovascular aortic repair
Patients treated with Gore Endovascular Aortic Products.
Device: Endovascular aortic repair
Treatment with Gore Endovascular Aortic Products.


Outcome Measures

Primary Outcome Measures :
  1. To collect "real world" data on the incidence of serious device events. [ Time Frame: Up to 10 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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: 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
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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