Twelve-Month Outcomes of the J-Tube Flow-Diverting Stent for Unruptured Intracranial Aneurysms: a Prospective Multicenter Study

Flow-diverting stents are widely used for the endovascular treatment of intracranial aneurysms. Prospective clinical evaluation of newly developed flow-diverting devices is necessary to characterize their procedural performance, angiographic efficacy, and safety outcomes. To report the 12-month clinical and angiographic outcomes of the J‑Tube flow-diverting stent in patients with unruptured intracranial aneurysms. This prospective, multicenter, single-arm study was conducted between September 2022 and June 2024 at nine tertiary clinical centers in China. A total of 149 patients were enrolled, of whom 148 received treatment with the J‑Tube flow-diverting stent. The primary efficacy endpoint was complete occlusion of the target aneurysm at 12 months. Secondary outcomes included procedural success, complete occlusion at 6 months, parent artery patency at 12 months, and device performance. Safety outcomes included all-cause mortality, stroke, adverse events, serious adverse events, target aneurysm hemorrhage, and device defects. A total of 157 J-Tube flow-diverting stents were implanted in 148 patients, resulting in a procedural success rate of 100