Preclinical safety and performance evaluation of a novel, open-cell intracranial vascular stent

We report a preclinical study of a novel intracranial vascular stent for aneurysm occlusion to test the hypothesis that the open-cell intracranial vascular stent developed in China have similar performance to the clinical stent.

The device's efficacy and safety were assessed in an elastase-induced rabbit aneurysm model. Technical success (complete coverage of the aneurysm neck), occlusion effects, arterial patency, and stent performance were evaluated at 1, 3, and 6 months post-implantation through a multi-modal assessment approach including angiography, detailed histological examination, and scanning electron microscopy (SEM).

We attempted to implant our test stents in 13 aneurysm models, with Stent-Assisted Coil Embolization (SACE), and compared them to 13 models implanted with commercially available intracranial stents. All 26 cases were successfully placed. The two groups had no significant difference in immediate postoperative occlusion success rates (p = 0.673). During follow-up, no in-stent stenosis or occlusion was observed. In the experimental group, all stented aneurysms showed progressive occlusion. There was no significant difference in occlusion effects between the two groups overall. The arterial branches covered by the stents remained patent (mTICI flow grade III), with good stent coverage. No significant differences were observed in stent system performance (p > 0.05).

The novel and open-cell intracranial vascular stent, designed to Stent-Assisted Coil Embolization, is a safe and effective device based on the evaluation results obtained in the rabbit aneurysm model. It shows no significant differences compared to clinically available stents, providing initial animal experimental evidence for potential future clinical applications.