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

To establish the preliminary safety and effectiveness of the SEAL™ Endovascular Aneurysm Lattice System for the treatment of saccular intracranial aneurysms.The data from this study will be used to support:EU CE Mark labellingUS FDA Investigational Device Exemption (IDE) approval support of PMA approval.

Inclusion Criteria:20 to 80 years of age at the time of screeningEvidence of a single unruptured aneurysm requiring treatment. If there is evidence of an additional aneurysm requiring treatment, the secondary aneurysm must also be treatable using a SEAL™ System Device, either during a single procedure or consecutive procedures.In these instances, no additional implanted devices are permissible except for as medically required for patient safety.Ruptured aneurysms may be included according the following criteria: The subject is neurologically stable with a Hunt and Hess scale of 3 or less at the time of treatmentModified Disability Scale (mRS) of ≤2 prior to presentation or ruptureThe index intracranial aneurysm (IA) to be treated must include the following features:Aneurysm features suitable for endovascular treatment with an intrasaccular device per the treating interventionist.Saccular morphologyLocated at a bifurcation, terminus, or sidewall in the anterior or posterior circulation3mm-25mm in dome diameterNarrow or wide-neck aneurysm with neck size ≥ 4mm or Dome-to-Neck (DN) ratio < 2Aneurysm treatment does not require the preplanned use of any additional implanted devicesSubject is able to maintain compliance with all aspects of screening, evaluation, treatment, and post-procedure follow-up scheduleBaseline mRS of 0-1 for unruptured casesAbility to obtain written informed consent from subject prior to the initiation of any study proceduresSubject has been approved for inclusion by Galaxy Therapeutics INC. clinical affairs team.Exclusion Criteria:Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.Aneurysms smaller than 3mm and larger than 25mm in dome diameter.Inability to access target aneurysm with microcatheter due to intracranial atherosclerosis, vessel tortuosity or poor aneurysm angle take-off.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.Proximal vessel tortuosity or morphology that could prohibit access to target aneurysmClinical, angiographic, or CT evidence of CNS arterial vasculitis, moyamoya disease, intracranial tumor (except small meningioma), or any other intracranial vascular malformationsPatients 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 daysPatients 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.Modified Rankin Scale (mRS) score of ≤ 2 prior to presentation or acute rupture (as applicable)SAH from non-index aneurysm or any other intracranial hemorrhage within the past 60 daysTarget aneurysm has been previously treated and contains devices, implants, or coils that could interfere with correct SEAL™ device placement.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.Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy, or hemoglobinopathyHypersensitivity that cannot be medically controlled to any component of the SEAL™ System, procedural materials, or medications commonly used during the procedureCurrently 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 schedulePresence of an acute life-threatening illness requiring treatmentLife-expectancy of < 5 yearsSubject has an uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the studySubject is a prisoner or member of other vulnerable population