Introduction The first-in-human PRE-SEAL IT trial was designed to assess the feasibility, safety, and effectiveness of the novel Saccular Endovascular Aneurysm Lattice (SEAL^TM) system in patients with previously untreated ruptured and unruptured wide-neck intracranial aneurysms (IA). Here, we present the final demographic, procedural, 24-hour, and 3-month safety and effectiveness results from the 33 aneurysm that were treated in 29 patients with the SEAL^TM device and enrolled in the PRE-SEAL IT study.

Methods PRE-SEAL IT is a prospective, interventional, core-lab adjudicated, single-arm study performed in Medellin, Columbia and Pakistan. From January 2022 through March 2023, 29 patients with 33 IAs were enrolled into the PRE-SEAL IT trial and follow-up is ongoing. Key inclusion criteria included: 1. Age 20-80 years, 2. Saccular shape, bifurcation, or terminus IA, 3.Wide neck aneurysm with neck size ≥4mm or dome-to-neck ratio <2, and 4. IA diameter 2mm to 25mm. Consented and enrolled patients were treated with the SEAL^TM device. A follow-up DSA was performed at 24-hours, 6 months, and 12 months and a MRA at 3 months. Angiographic occlusion (Roy Raymond (RR) and Web Occlusion Scale (WOS)) was adjudicated by an independent interventional neuroradiologist (Oculus Imaging, TN, USA).

Results In 29 patients (twenty-two women and 7 men), 33 IAs were treated with the SEAL^TM device, with a mean age of 61.0± 13.5 years. Of the 33 IAs, the majority were anterior circulation (81.8%), bifurcation (75.8%), and unruptured (87.9%). Mean aneurysm width was 6.1 ± 3.0mm, with a mean neck size of 4.2±1.7mm and mean neck to dome ratio of 1.4±0.4. The SEAL Arc was used in 48.5% and SEAL Base in 51.5% of cases. No technical complications were observed in the study and technical success was achieved in 100% of cases. Immediate post-procedure complete occlusion (Grade A, B) was achieved in 4 patients (12.1%) and adequate occlusion (Grade A, B, C) in 8 (24.2.%). At 24-hour follow-up, 12 patients (36.4%) had complete occlusion, and 19 patients (57.6%) achieved adequate occlusion. At 3 months, 20/27 (74.1%) (RR I and WOS A), achieved complete occlusion, and 22/27 (81.5%) achieved adequate occlusion (RR I and II). No cases of peri-procedural stroke or new subarachnoid hemorrhage were reported up to the 3 month follow-up.

Conclusion The final procedural, 24-hour, and 3-month follow-up results of the PRE-SEAL-IT trial demonstrated promising occlusion rates at post-procedural, 24-hour, and 3 months follow-up with no safety concerns.

Disclosures B. Pabón: None. V. Torres: None. S. Zaidi: None. H. Salahuddin: None. M. Patiño: None. F. Peláez: None. J. Mútis: None. M. Cardozo: None. A. Hussain: None. I. Lutfi: None. M. Ali: None. S. Ahmed: None. E. Pereira: None. A. Badruddin: None. K. Woodward: None. T. Wolfe: None. C. Langerford: None. B. Jankowitz: None. V. Costalat: None. D. Altschell: None. M. Kaffashi: None. O. Zaidat: None.