Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

a study on Abdominal Aortic Aneurysm Aneurysm

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around
Principal Investigator
by Anthony Chau, M.D.

Description

Summary

A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.

Official Title

Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Details

The purpose of the Gore Together Aortic Registry is to collect real-world data (RWD) for Gore aortic endovascular devices. Due to the nature of the program, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.

Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.

Keywords

AAA - Abdominal Aortic Aneurysm, Aneurysm, Aneurysm Repair, Endovascular, EVAR, Endoprosthesis, Aortic, Aortic Repair, Abdominal Aortic Aneurysm, GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device), GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device)

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • University of California - Irvine accepting new patients
    Irvine California 92697 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
W.L.Gore & Associates
ID
NCT06218875
Study Type
Observational [Patient Registry]
Participants
Expecting 2000 study participants
Last Updated
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