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 (SEALTM) 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 SEALTM 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 SEALTM 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 SEALTM 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.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.