Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization
NCT07304102 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-12-26
Summary
The IBE 25-05 study will be a prospective, non-randomized, multicenter, interventional two arm evaluation designed to assess the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease.
Conditions
- Common Iliac Artery Aneurysm
- Aorto Iliac Aneurysm
Interventions
- DEVICE
-
GORE® EXCLUDER® IBE Plus Stent Graft
Endovascular aneurysm repair with the GORE® EXCLUDER® IBE Plus Stent Graft
Sponsors & Collaborators
-
W.L.Gore & Associates
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-03-31
- Completion
- 2032-08-31
- FDA Device
- Yes
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