A110 First US prospective study on pipeline shield with 1-year outcomes in 180+ patients

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Background/Introduction Introduction: Pipeline™ Shield Post-Approval Study (PAS) collects safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) with Pipeline™ Shield. Objective/Purpose Objective: This is the first PAS evaluating Pipeline™ Shield following commercial approval in the U.S. Outcomes and safety data at 6-Months and 1-Year are presented based on available follow-up. Methods/Case Description Methods: Patients with IAs in ICA, per US label, were prospectively enrolled and will be followed for 3Y. Site data are monitored, safety data assessed by independent clinical events committee, and angiographic data by an independent core laboratory. Primary effectiveness endpoint is complete occlusion of the target aneurysm without significant parent artery stenosis (≤ 50%), and without retreatment. Data on all serious adverse events will be collected for safety evaluation. Results/Findings Results: Between December 2021-2024, 246 patients were enrolled at 16 U.S. sites, with 237 patients undergoing Pipeline™ Shield implantation. Most target aneurysms were previously untreated (94.5%) and unruptured (96.2%). Most common ICA locations were ophthalmic (55.7%), clinoid (24.3%), and communicating (14.0%). Complete aneurysm occlusion was achieved in 73.4% at 6M and 82.9% at 1Y. Favorable functional outcome (mRS ≤2) was reported in 99.0% at 6M and 98.5% at 1Y. Rates of significant parent artery stenosis were low (6M: 2.3%; 1Y: 3.3%), as were retreatment rates (≤1.6%). Through 1Y, minor ischemic events occurred in 3.8% of patients and intracranial hemorrhage in 1.3%, without occurrence of major stroke or death. Discussion/Conclusions/Learning Points Conclusion The Pipeline™ Shield PAS provides strong evidence that Pipeline™ Shield is a safe and effective treatment option for ICA aneurysms.

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