Background Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. Objective To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. Methods Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b–3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a −10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0–2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). Results From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12–20). In the primary analysis population (n=107), eTICI 2b–3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b–3 was observed in 73.8% (79/107), with first pass eTICI 2b67–3 in 69.2% (74/107) and eTICI 2c–3 in 48.6% (52/107). Median number of passes was 1 (IQR 1–2). Final eTICI 2b–3 rate was 99.1% (106/107); final eTICI 2b67–3 rate was 91.6% (98/107); final eTICI 2c–3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0–2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). Conclusions The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. Trial registration number NCT04514562.

This study provides an objective comparison of cranial computed tomography (CT) imaging quality and radiation dose between photon counting detectors (PCCTs) and energy-integrated detectors (EIDs). We retrospectively analyzed 158 CT scans from 76 patients, employing both detector types on the same individuals to ensure a consistent comparison. Our analysis focused on the Computed Tomography Dose Index and the Dose-Length Product together with the contrast-to-noise ratio and the signal-to-noise ratio for brain gray and white matter. We utilized standardized imaging protocols and consistent patient positioning to minimize variables. PCCT showed a potential for higher image quality and lower radiation doses, as highlighted by this study, thus achieving diagnostic clarity with reduced radiation exposure, underlining its significance in patient care, particularly for patients requiring multiple scans. The results demonstrated that while both systems were effective, PCCT offered enhanced imaging and patient safety in neuroradiological evaluations.