Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascula… (NCT07304102) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization
100 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The target lesion and surrounding vasculature are amenable to treatment with IBE Plus system requirements:
✓.1. Common iliac artery to be treated must have a common iliac diameter ≥ 25 mm with or without concomitant abdominal aortic aneurysm 1.2. Minimum diameter ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.3. Intended treatment length must be ≥ 100 mm in unilateral application or a combination of ≥ 100 mm and ≥ 150 mm in bilateral application 1.4. The planned distal target landing zone within the internal iliac artery is within the trunk of the internal iliac artery with at least 15 mm of seal zone 1.5. Iliac vasculature meets anatomical specifications for selected VBX Stent Graft(s)
✓. Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices
✓. Informed Consent Form (ICF) is signed by subject
✓. Subject is capable of complying with protocol requirements, including follow-up
✓. Life expectancy \> 2 years
✓. Age ≥ 22 years at time of informed consent signature
✓. Male or infertile female
Exclusion criteria
✕. Mycotic or ruptured aneurysm
✕. ASA class V (moribund patient not expected to live 24 hours with or without operation)
✕. Renal insufficiency defined as creatinine \> 1.8 mg/dL or undergoing dialysis
What they're measuring
1
Freedom From Composite of the Following: All-Cause Mortality, Serious Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Function Decline, Conversion to Open Surgical Repair
Timeframe: Through 30 days post-treatment
2
Freedom From Composite of the Following: IBE Plus-Related Reinterventions Involving Type Ib / Ic or Type III Endoleak, Total Occlusion of Any IBE Plus Component, Loss of Primary Patency of the Internal Iliac Device Component
✕. Dissected, heavily calcified, or heavily thrombosed landing zone(s)
✕. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
✕. Participating in another investigational drug or medical device study within one year of study enrollment
✕. An active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection. Subjects with a chronic infection (such as HIV, Hepatitis C, etc.) that is well controlled under their current treatment regimen may be eligible