Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial

Exclusion Criteria

• •1. Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
• •2. Aneurysms smaller than 3mm and larger than 25mm in dome diameter.
• •3. Inability to access target aneurysm with microcatheter due to intracranial atherosclerosis, vessel tortuosity or poor aneurysm angle take-off.
• •4. Presence of vascular disease or other vascular abnormality that could prohibit access to index aneurysm such carotid stenosis or diminished caliber of the target artery.
• •5. Proximal vessel tortuosity or morphology that could prohibit access to target aneurysm
• •6. Clinical, angiographic, or CT evidence of CNS arterial vasculitis, moyamoya disease, intracranial tumor (except small meningioma), or any other intracranial vascular malformations
• •7. Patients with high risk for recurrent ischemic stroke due to previous history of intracranial ischemic stroke symptoms such as transient ischemic attacks (TIAs), minor, or major strokes within the past 60 days
• •8. Patients with hemodynamic or medical compromise due to medical comorbidities such as severe unstable congestive heart failure (ejection fraction \<30%) or severe COPD requiring home oxygen.
• •9. Modified Rankin Scale (mRS) score of ≤ 2 prior to presentation or acute rupture (as applicable)
• •10. SAH from non-index aneurysm or any other intracranial hemorrhage within the past 60 days
• •11. Target aneurysm has been previously treated and contains devices, implants, or coils that could interfere with correct SEAL™ device placement.
• •12. Subject is pregnant or a lactating female (For females of child-bearing potential, a positive pregnancy test within 7 days of the day of procedure or refusal to use a medically accepted method of birth control for the duration of the study.
• •13. Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy, or hemoglobinopathy
• •14. Hypersensitivity that cannot be medically controlled to any component of the SEAL™ System, procedural materials, or medications commonly used during the procedure
• •15. Currently enrolled in another investigational study or post-market study that could affect the safety and efficacy of aneurysm treatment or interfere with the study follow- up schedule
• •16. Presence of an acute life-threatening illness requiring treatment
• •17. Life-expectancy of \< 5 years
• •18. Subject has an uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study
• •19. Subject is a prisoner or member of other vulnerable population