Abstract Number ‐ 5: Interim Results of PRE‐SEAL IT Saccular Endovascular Aneurysm Lattice System First in Human Interventional Trial

Abstract

Introduction Preliminary in vivo animal intracranial aneurysm (IA) studies have demonstrated promising immediate and follow‐up aneurysm occlusion rates using the novel Saccular Endovascular Aneurysm Lattice (SEAL) system. The PRE‐SEALTM IT trial was designed to assess the feasibility, safety, and effectiveness of the SEAL system in patients with previously untreated ruptured and unruptured wide‐neck IA. Methods PRE‐SEAL IT is an on‐going, prospective, interventional, core‐lab adjudicated, single‐arm study performed in Medellin, Columbia. Key inclusion criteria included: 1. Age 20–80 years, 2. Saccular shape, bifurcation, or terminus IA, 3. Wide neck aneurysm with neck size ≥4 mm 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. Final clinical follow‐up was at 24‐months. Primary efficacy outcome was achieving complete occlusion (WOS grade A or B) at 6 months angiographic follow up. Primary safety outcome was any stroke with an increase in NIHSS of 4 up to discharge. Results From December 2021 through June 2022, 15 patients have been enrolled into the PRE‐SEAL IT trial. Ten women and 5 men were treated with the SEAL device, with a mean age of 56.8±9.5 years. Of the 15 IA, 12 were anterior circulation (ICA‐T (1), MCA (7), AcomA (3), A2‐A3 (1)) and 3 posterior circulations (Basilar, VBJ‐fenestration, SCA), and 14 were unruptured (93.3%). Mean aneurysm width was 6.1±2.5mm. Immediate post‐procedure complete occlusion (Grade A, B) was achieved in 9 patients (60%) and adequate occlusion (Grade A, B, C) in 13 (86.6%). At 24‐hours follow‐up, 12 patients (80%) had complete occlusion and 15 (100%) achieved adequate occlusion. Six‐month complete occlusion rate (Grade A and B) was 100% (8/8). Interim results were site adjudicated. No cases of intraoperative rupture, or bleeding or re‐bleeding, or clinical stroke were observed. Conclusions The interim results of the PRE SEAL‐IT trial demonstrated promising complete occlusion rates at 24‐hour and 6 month follow‐up with no safety concerns. Trial enrollment will be completed in October, and final 24‐hour results will be presented at the 2022 SVIN Annual Meeting.