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Updated: Aug 21, 2026
Microsurgical Clip Obliteration of Middle Cerebral Aneurysm Using Intraoperative Flow Assessment
Published on: September 25, 2009
Twelve-Month Outcomes of the J-Tube Flow-Diverting Stent for Unruptured Intracranial Aneurysms: a Prospective
Jingwei Li1, Jie Zhang2, Youxiang Li3
1Xuan Wu Hospital of the Capital Medical University, Beijing, China.
Background:
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.
Objective:
To report the 12-month clinical and angiographic outcomes of the J‑Tube flow-diverting stent in patients with unruptured intracranial aneurysms.
Methods:
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.
Results:
A total of 157 J-Tube flow-diverting stents were implanted in 148 patients, resulting in a procedural success rate of 100%. Complete aneurysm occlusion rates at 6 months were 73.9% in the full analysis set and 74.8% in the per-protocol set. At 12 months, complete occlusion rates were 87.2% and 90.8%, respectively. Parent artery patency was observed in 136 of 140 evaluable patients (97.1%). Mid-stent stenosis of greater than 50% was observed in four patients (2.9%), whereas no stenosis was observed at the proximal or distal stent ends. No patient underwent clinically driven target vessel revascularization because of parent artery stenosis. Eight patients (5.4%) experienced stroke within 12 months. No target aneurysm rupture or device defect was observed.
Conclusion:
In this prospective, multicenter, single-arm study, the J‑Tube flow-diverting stent showed high technical success and favorable 12-month angiographic outcomes in selected patients with unruptured intracranial aneurysms. Because no comparative device group was included, these findings should be interpreted as preliminary clinical evidence of feasibility and safety rather than evidence of superiority over existing flow diverters. Further comparative and longer-term studies are warranted to confirm these findings.
