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Published on: October 1, 2017
Endovascular Treatment of Intracranial Aneurysms with TaminoVIA Intracranial Stent System: a Prospective,
Guoli Duan1,2, Yuhang Zhang1,2, Rui Zhao1,2
1Department of Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.
Objectives:
To conduct a comprehensive comparative assessment of clinical performance between the novel TaminoVIA stent and the LVIS stent for endovascular treatment of unruptured intracranial aneurysms (UIAs).
Methods:
This prospective, multi-center, randomized, open-label, parallel positive-controlled, non-inferiority trial was conducted by 13 centers in China. Patients with UIAs were randomized in a 1:1 ratio to receive endovascular treatment (EVT) with the TaminoVIA stent or the LVIS stent. The primary outcome was successful occlusion at 6‑month follow-up, assessed by a blinded core laboratory. The non-inferiority boundary was set at 12%. Secondary outcomes included immediate procedural success, recanalization rates, and safety endpoints.
Results:
Between March 2022 and April 2024, 203 patients were enrolled and randomized. Full Analysis Set (FAS) analysis showed a 6-month successful occlusion rate of 89.90% (89/99) in the TaminoVIA stent group, compared to 87.00% (87/100) in the LVIS stent group, with a difference of +2.90% (95% CI, -5.97% to 11.77%; P < 0.01). Immediate occlusion rates were comparable (68.89% vs. 61.54%; P = 0.35), and recanalization rates at 6 months were identical (1.11% vs. 1.10%; P > 0.99). The incidence of severe adverse events (SAEs, 13.13% vs. 15.00%, P = 0.84), device-related complications (2.02% vs. 0%, P = 0.25) and procedure-related SAEs (2.02% vs. 2.00%, P > 0.99) were comparable between the two groups. Both PPS and FAS analyses exceeded the non-inferiority boundary.
Conclusions:
The TaminoVIA stent demonstrated non-inferiority to LVIS in both efficacy and safety for IA embolization. These findings support its clinical adoption, though long-term durability requires further validation.
Clinical Trial Registration Number:
ChiCTR2400092436.
