Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07304102
Eligibility Criteria:
Primary Arm Inclusion Criteria
The subject is / has:
1. The target lesion and surrounding vasculature are amenable to treatment with IBE Plus system requirements:
1.1. 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)
2. Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices
3. Informed Consent Form (ICF) is signed by subject
4. Subject is capable of complying with protocol requirements, including follow-up
5. Life expectancy \> 2 years
6. Age ≥ 22 years at time of informed consent signature
7. Male or infertile female
Secondary Arm Inclusion Criteria
The subject is / has:
1. Present with any one of the following treatment indications:
1.1. The subject has a confirmed Type Ib endoleak of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. Minimum diameter of ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.2. The subject has documented diameter growth of the common iliac artery of at least ≥ 5 mm in the presence of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. 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
2. Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices
3. Informed Consent Form (ICF) is signed by subject
4. Subject is capable of complying with protocol requirements, including follow-up
5. Life expectancy \> 2 years
6. Age ≥ 22 years at time of informed consent signature
7. Male or infertile female
Primary Arm and Secondary Arm Exclusion Criteria
The subject is / has:
1. Mycotic or ruptured aneurysm
2. ASA class V (moribund patient not expected to live 24 hours with or without operation)
3. Renal insufficiency defined as creatinine \> 1.8 mg/dL or undergoing dialysis
4. NYHA class IV
5. Dissected, heavily calcified, or heavily thrombosed landing zone(s)
6. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
7. Participating in another investigational drug or medical device study within one year of study enrollment
8. 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
9. Degenerative connective tissue disease, e.g., Marfan's or Ehler-Danlos Syndrome
10. Planned concomitant surgical procedure or major surgery within 30 days of treatment date
11. History of drug abuse, e.g., cocaine or amphetamine, within 1 year of treatment
12. Known sensitivities or allergies to the device materials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT07304102
Study Brief:
Protocol Section:
NCT07304102