Introduction Despite the proven benefit of stent retrievers, challenges to rapid revascularization of large vessel occlusions (LVO) persist. The NeVa Stent Retriever (NeVa) is a novel stent retriever designed with openings in the basket cell structure (‘drop zones’) intended to capture organized thrombi.
Aim of Study To evaluate NeVa safety and performance for recanalizing occluded intracranial vessels.
Methods CLEAR was a prospective, multicenter, open label, single-arm, FDA-regulated IDE study. Core Lab adjudicated efficacy endpoints were recanalization rates, 90-day mRS 0–2; CEC assessed safety endpoints included: 90-day mortality, symptomatic ICH, and Serious Adverse Events related to procedure/device(PRSAE/DRSAE).
Results A total of 139 subjects were enrolled at 25 centers in the US and Europe. Mean age was 67 ± 13 years; 47% were female. Median NIHSS score was 16 (IQR: 12–20). Occlusions were located in ICA (10%), M1 (61%), M2 (27%), Basilar (1%), and PCA (1%). Mean time to first pass was 19 ± 12 minutes.
First-pass to eTICI 2b-3 occurred in 68.3% and to FPE (to eTICI 2c-3) was observed in 46.8%, eTICI 2c-3 within 3 NeVa passes occurred in 73.4% and eTICI 2b-3 in 89.9%; Final eTICI 2b-3 was achieved in 95.0%; and final eTICI 2c-3 in 74.8%. A good outcome (90-day mRS 0–2) was seen in 63%. CEC reported DRSAEs in 4.3% and PRSAE’s in 5.8% of subjects. Mortality was 9.4% with sICH in 5.8% of subjects.
Conclusion NeVa is effective and safe for revascularization of LVO strokes and demonstrates high first-pass success with strong association with functional independence.
Disclosure of Interest Nothing to disclose.
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