Global Registry Study of the SEAL17 System for Treating Wide Neck Intracranial Aneurysms Up to 20 mm

What this Trial Is About

Researchers are studying patients with wide-neck intracranial aneurysms, either unruptured or ruptured, that are 20 mm or smaller in diameter and require treatment. This international, prospective, single-arm, multicenter registry study evaluates the use of the SEAL System device for treating these aneurysms. The study aims to collect clinical, imaging, and safety data to better understand treatment outcomes over time. Participants will receive treatment with the SEAL Device, which is delivered using standard endovascular techniques through microcatheters to the aneurysm site. The device is positioned inside the aneurysm and detached electrically by the operator. The study includes follow-up imaging at 24 hours or hospital discharge, then at 3 months, 6 months, and a required 12-month angiographic evaluation. Annual follow-ups continue for up to five years after the procedure. During the study, participants will undergo clinical assessments and imaging tests to monitor aneurysm occlusion and safety. The primary outcome is the proportion of subjects with successful aneurysm closure at 12 months without artery narrowing or need for retreatment, as assessed by an independent lab. Follow-up visits include angiographic studies and clinical evaluations, ensuring long-term safety and effectiveness monitoring. Total participation may last five years post-treatment.

SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry