Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:27 PM
Study NCT ID:
NCT07304102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization
Sponsor:
W.L.Gore & Associates
Organization:
Study Overview
Official Title:
Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: