NCT07304102

Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goal of this clinical trial is to evaluate the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft for endovascular revascularization in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease requiring intervention. The study population includes adults aged 22 years and older, both male and infertile female, who meet specific anatomical criteria. The main questions it aims to answer are: Does the IBE Plus Stent Graft provide clinical benefit and maintain safety? Does the device maintain effectiveness? Researchers will evaluate two parallel study arms: * Primary Arm: Subjects with AIAA/CIAA pathology, including a subset newly eligible for treatment with IBE Plus. * Secondary Arm: Subjects requiring EVAR revision for previously treated AIAA/CIAA. Participants will: * Undergo pre-procedure assessments (informed consent, physical exam, lab tests, and CTA imaging). * Receive endovascular treatment with the IBE Plus Stent Graft. * Attend follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-procedure for physical exams, lab tests, and imaging. * Be monitored for adverse events, device performance, and need for reintervention.

Conditions

• Common Iliac Artery Aneurysm
• Aorto Iliac Aneurysm

Interventions

Type	Name	Description
DEVICE	GORE® EXCLUDER® IBE Plus Stent Graft	Endovascular aneurysm repair with the GORE® EXCLUDER® IBE Plus Stent Graft

Timeline

• Start date: 2026-09-01
• Primary completion: 2028-03-01
• Completion: 2032-08-01
• First posted: 2025-12-26
• Last updated: 2025-12-26

Regulatory

• FDA-regulated device study