Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Tracking Information
First Submitted Date August 3, 2012
First Posted Date August 7, 2012
Last Update Posted Date October 2, 2019
Study Start Date December 2010
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2012)
To collect "real world" data on the incidence of serious device events. [ Time Frame: Up to 10 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Global Registry for Endovascular Aortic Treatment (GREAT)
Official Title 'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation
Brief Summary Prospective, observational Registry to obtain data on device performance and clinical outcomes.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Consecutive series of patients who undergo treatment with Gore endovascular aortic products.
Condition Multiple Pathologies
Intervention Device: Endovascular aortic repair
Treatment with Gore Endovascular Aortic Products.
Study Groups/Cohorts Endovascular aortic repair
Patients treated with Gore Endovascular Aortic Products.
Intervention: Device: Endovascular aortic repair
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 27, 2016)
4625
Original Estimated Enrollment
 (submitted: August 3, 2012)
2500
Estimated Study Completion Date September 2026
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Brazil,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01658787
Other Study ID Numbers GRT 10-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party W.L.Gore & Associates
Study Sponsor W.L.Gore & Associates
Collaborators Not Provided
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
PRS Account W.L.Gore & Associates
Verification Date October 2019