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Objectives <p>To conduct a&#xa0;comprehensive comparative assessment of clinical performance between the novel TaminoVIA stent and the LVIS stent for endovascular treatment of unruptured intracranial aneurysms (UIAs).</p> Methods <p>This prospective, multi-center, randomized, open-label, parallel positive-controlled, non-inferiority trial was conducted by 13&#xa0;centers in China. Patients with UIAs were randomized in a&#xa0;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&#xa0;blinded core laboratory. The non-inferiority boundary was set at 12%. Secondary outcomes included immediate procedural success, recanalization rates, and safety endpoints.</p> Results <p>Between March 2022 and April 2024, 203 patients were enrolled and randomized. Full Analysis Set (FAS) analysis showed a&#xa0;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&#xa0;difference of +2.90% (95% CI, −5.97% to 11.77%; <i>P</i> &lt; 0.01). Immediate occlusion rates were comparable (68.89% vs. 61.54%; <i>P</i> = 0.35), and recanalization rates at 6&#xa0;months were identical (1.11% vs. 1.10%; <i>P</i> &gt; 0.99). The incidence of severe adverse events (SAEs, 13.13% vs. 15.00%, P = 0.84), device-related complications (2.02% vs.&#xa0;0%, <i>P</i> = 0.25) and procedure-related SAEs (2.02% vs. 2.00%, <i>P</i> &gt; 0.99) were comparable between the two groups. Both PPS and FAS analyses exceeded the non-inferiority boundary.</p> Conclusions <p>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.</p> <p>Clinical Trial registration number: ChiCTR2400092436.</p>

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Endovascular Treatment of Intracranial Aneurysms with TaminoVIA Intracranial Stent System: a Prospective, Multicenter, Randomized, Parallel Positive-controlled, Non-inferiority Trial

  • 期刊论文

  • 发表日期：

    2025年10月6日

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  • Guoli Duan,
  • Yuhang Zhang,
  • Rui Zhao,
  • Pengfei Yang,
  • Jieqing Wan,
  • Xuebin Hu,
  • Ting Lei,
  • Lei Wang,
  • Ge Gao,
  • Sheng Guan,
  • Jing Xu,
  • Shu Wan,
  • Wenfeng Feng,
  • Qingdong Guo,
  • Bo Ying,
  • Li Zhang,
  • Zhe Li,
  • Qiang Li,
  • Jianmin Liu

摘要

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.