Observational registry for patients treated with GORE® endovascular devices for abdominal aortic aneurysms
Official title: Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Run by W.L.Gore & Associates · NCT06218875 · Data updated 2026-11-12
This study is tracking patients who have been treated with GORE® devices for abdominal aortic aneurysms to see how they do over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | W.L.Gore & Associates Industry-sponsored |
| Locations | 90 sites (Little Rock, Arkansas and 89 other locations) |
| Status | Recruiting |
| Started | May 7, 2024 |
| Main results expected | September 30, 2042 |
| Study ends | September 30, 2042 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT06218875 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are being treated with the GORE® endovascular devices.
✕Probably not a fit
Patients who are unlikely to attend follow-up visits or are enrolled in concurrent studies may not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry collects real-world data on patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis. The study aims to follow patients for up to 10 years post-procedure to assess outcomes and any issues related to the devices. Patient selection and treatment interventions will be determined by physicians based on standard clinical practice, ensuring that the data reflects routine care. Participants will attend regular follow-up visits and report any concerns to their healthcare providers.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term effectiveness and safety of GORE® endovascular devices for treating abdominal aortic aneurysms.
How similar studies have gone: Other observational studies have successfully collected real-world data on similar endovascular devices, indicating a precedent for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements 2. Patient has been or is intended to be treated with an eligible registry device 3. Patient is age ≥ 18 years at time of informed consent signature. Exclusion Criteria: 1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures. 2. Patient with exclusion criteria required by local law. 3. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
Where it's running
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Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States Recruiting -
University of California - Irvine
Irvine, California, United States Recruiting -
University of Southern California
Los Angeles, California, United States Recruiting -
University of Southern California
Los Angeles, California, United States Recruiting -
Stanford University School of Medicine
Palo Alto, California, United States Recruiting -
Stanford University School of Medicine
Stanford, California, United States Recruiting
Show 44 more locations
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Mount Sinai Vascular Institute
Miami Beach, Florida, United States Recruiting -
University of South Florida
Tampa, Florida, United States Recruiting -
University of South Florida
Tampa, Florida, United States Recruiting -
VA Medical Center- Atlanta
Atlanta, Georgia, United States Recruiting -
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States Recruiting -
Augusta University Medical Center
Augusta, Georgia, United States Recruiting -
Atlanta VA Medical Center
Decatur, Georgia, United States Recruiting -
University of Chicago Hospital
Chicago, Illinois, United States Recruiting -
Endeavor Health
Evanston, Illinois, United States Recruiting -
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, United States Recruiting -
University of Louisville
Louisville, Kentucky, United States Recruiting -
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States Recruiting -
University of Maryland - Baltimore
Baltimore, Maryland, United States Recruiting -
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
McLaren Heatlh Care Corporation
Bay City, Michigan, United States Recruiting -
Corewell Health Medical Group West
Grand Rapids, Michigan, United States Recruiting -
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
University of Missouri
Columbia, Missouri, United States Recruiting -
Cox Health
Springfield, Missouri, United States Recruiting -
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting -
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting -
University at Buffalo, Research Foundation
Buffalo, New York, United States Recruiting -
Mission Hospital
Asheville, North Carolina, United States Recruiting -
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States Recruiting -
Duke University Medical Center
Durham, North Carolina, United States Recruiting -
Duke Universtiy Medical Center
Durham, North Carolina, United States Recruiting -
Forsyth Medical Center
Winston-Salem, North Carolina, United States Recruiting -
Wake Forest Baptist
Winston-Salem, North Carolina, United States Recruiting -
Wake Forest Baptist
Winston-Salem, North Carolina, United States Recruiting -
University Hospitals - Cleveland Medical Center
Cleveland, Ohio, United States Recruiting -
Portland VA Health Care System
Portland, Oregon, United States Recruiting -
Portland VA Health Care System
Portland, Oregon, United States Recruiting -
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
Prisma Health-Upstate
Greenville, South Carolina, United States Recruiting -
Prisma Health-Upstate
Greenville, South Carolina, United States Recruiting -
UT Southwestern Medical Center
Dallas, Texas, United States Recruiting -
HCA Healthcare Research Institute/Columbia Medical Center of Plano
Plano, Texas, United States Recruiting -
Baylor Scott and White
Plano, Texas, United States Recruiting -
Intermountain Health
Murray, Utah, United States Recruiting -
Intermountain Health
Murray, Utah, United States Recruiting -
University of Utah
Salt Lake City, Utah, United States Recruiting
+40 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: S. Han — University of Southern California
- Study coordinator: Karen Martin
- Email: kgmartin@wlgore.com
- Phone: 928-864-2223
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Heli-FX EndoAnchor system in abdominal aortic aneurysm patients in China
This study tests whether the Heli-FX EndoAnchor device can safely and effectively help seal and fix AAA patients at high risk of endoleaks or migration after repair.
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TUVA BX and iCover stent grafts used in BEVAR for complex aortic aneurysms
This study looks at whether the TUVA BX and iCover stent grafts used during BEVAR procedures are safe and perform well in real-world patients with complex abdominal or thoracoabdominal aneurysms.
-
Retreatment with the Nectero EAST System for abdominal aortic aneurysm
This will try retreatment with the Nectero EAST System to repair infrarenal abdominal aortic aneurysms in adults who previously received the device under the initial protocol.
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Abdominal CT offered alongside lung screening for people who have smoked
We will test whether mentioning a possible extra abdominal CT in the lung screening invitation changes whether people aged 55–70 who have ever smoked attend their lung screening appointment.
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Evaluating outcomes of endovascular abdominal aortic aneurysm repair
This study is testing two different devices for repairing abdominal aortic aneurysms to see which one works better for patients over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.