NCT06218875 Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
| NCT ID | NCT06218875 |
| Status | Recruiting |
| Phase | — |
| Sponsor | W.L.Gore & Associates |
| Condition | AAA - Abdominal Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-05-07 |
| Primary Completion | 2042-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2024-05-07 with a primary completion date of 2042-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
S. Han
PRINCIPAL INVESTIGATOR
University of Southern California
Frequently Asked Questions
Who can join the NCT06218875 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AAA - Abdominal Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06218875 currently recruiting?
Yes, NCT06218875 is actively recruiting participants. Contact the research team at kgmartin@wlgore.com for enrollment information.
Where is the NCT06218875 trial being conducted?
This trial is being conducted at Little Rock, United States, Irvine, United States, Los Angeles, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06218875 clinical trial?
NCT06218875 is sponsored by W.L.Gore & Associates. The principal investigator is S. Han at University of Southern California. The trial plans to enroll 2,000 participants.