Observational registry for patients treated with GORE® endovascular devices for abdominal aortic aneurysms
Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
W.L.Gore & Associates · NCT06218875
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | W.L.Gore & Associates (industry) |
| Locations | 90 sites (Little Rock, Arkansas and 89 other locations) |
| Trial ID | NCT06218875 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are being treated with the GORE® endovascular devices.
Not a fit: Patients who are unlikely to attend follow-up visits or are enrolled in concurrent studies may not benefit from this registry.
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 performed: Other observational studies have successfully collected real-world data on similar endovascular devices, indicating a precedent for this approach.
Eligibility criteria
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 this trial is running
Little Rock, Arkansas and 89 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: AAA - Abdominal Aortic Aneurysm, Aneurysm, Aneurysm Repair, Endovascular, EVAR, Endoprosthesis, Aortic, Aortic Repair