Abstract 493: Update on the Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial (SEAL™ IT)

Introduction Preclinical animal experiments and initial feasibility studies in humans have shown encouraging outcomes using the novel Saccular Endovascular Aneurysm Lattice (SEAL™) system for the treatment of both ruptured and unruptured wide‐neck intracranial aneurysms (IAs). The SEAL™ Interventional Pivotal IDE PMA Trial (SEAL™ IT) is designed to assess the safety and efficacy of the SEAL™ in patients with saccular IAs. This ongoing, prospective, multicenter trial includes three study arms and will enroll a total of 279 participants with wide‐neck bifurcation (WNBA), sidewall (SW), or acutely ruptured IAs across 50 U.S. sites. Methods Eligibility requirements include patients aged 20‐80 years with a wide‐neck saccular intracranial aneurysm (2‐19 mm) deemed suitable for treatment with the SEAL™ Intrasaccular Device (SID). Participants receive treatment using the SEAL™ device (Galaxy Therapeutics Inc.) and are monitored at discharge, and again at 3, 6, and 12 months, followed by yearly assessments for up to 5 years. The primary efficacy outcome is defined as complete aneurysm occlusion at 12 months without evidence of parent vessel stenosis or the need for retreatment, as determined by an independent core laboratory. Key safety outcomes include neurological death within 12 months, stroke occurring within the first 30 days, and ipsilateral stroke between 30 days and 1 year. Results As of submission, 163 WNBA, 58 WNSW, and 33 ruptured for a total of 254 patients (76.3% female; mean age 61.7 ± 11.3) have been enrolled at 50 sites. Mean aneurysm width was 5.2 ± 2.1, neck size of 3.7 ± 1.4, and neck‐to‐dome ratio of 1.4 ± 0.32. SEAL Arc was used in 63.6% and SEAL Base in 36.4%. Technical device success rate is 100% for WNBA, 94.8% WNSW, and 97.0% ruptured. The interim complete occlusion rate for the primary group is 84.5% at most recent date based on available imaging. Conclusion Preliminary data for the SEAL™ intrasaccular device is promising; Safety and effectiveness updates will be presented at the SVIN Conference.