Introduction: First-pass effect (FPE) is associated with improved clinical outcomes and reduced mortality in mechanical thrombectomy (MT) for large vessel occlusion strokes (LVOS). However, FPE is achieved in only 30-40% of patients with the current devices. The RapidPulse TM Cyclic Aspiration System (RP) is a novel technology consisting of a valve box that precisely cycles pressure from full to no vacuum multiple times per second adding kinetic energy to the suction forces. Initial clinical evaluation suggests that the system can achieve FPE rates in the 70% range. We aim to evaluate the RP as a frontline approach in LVOS. Methods: Prospective, multicenter, open-label, core lab adjudicated, two-arm study comparing the safety and efficacy of the RP System with non-randomized retrospective controls who were consecutively treated at the study sites based on similar eligibility criteria. Patients with LVOS involving the anterior or posterior circulations in whom the target lesion could be treated with the Medtronic React 71 aspiration catheter up to 24 hours from stroke onset were included in the RP arm. Controls consisted of comparable patients treated with 070-072 ID catheters. The primary outcome was the rate of FPE (complete/near reperfusion [mTICI ≥2c] after a single pass). Secondary outcomes include frontline technical success (defined as mTICI ≥2b after final device pass with no rescue therapy), final mTICI after all passes, symptomatic ICH, device-related complications, the proportion of patients achieving a modified Rankin Scale score of 0-2 at 90 days, and all-cause 90-day mortality. The study will enroll a maximum of 100 participants in the RP and 200 in the control arm at 5 centers in Spain, Turkey, Denmark, Latvia, and Brazil. Results: Final results will be presented at the conference. Conclusion: RapidPulseFS is the first prospective clinical trial aiming to compare cyclic versus standard aspiration technologies. This novel device may allow clinicians to achieve faster and better reperfusion while significantly reducing the disposable device costs associated with treating LVOS (ClinicalTrials.gov Identifier: NCT05122637).

Background Occlusive thrombi in acute ischemic stroke can be in various types which limits the success of the thrombectomy. The NeVaTM (Vesalio, Nashville, Tennessee) thrombectomy device was originally designed for all types of clot. Our aim was to evaluate the efficacy and safety of the NeVaTM device for mechanical thrombectomy. Methods Retrospective review of prospectively collected mechanical thrombectomy database revealed 145 patients who had fullfilled the inclusion criteria. The data collected includes clinical patient characteristics, procedural measures, timestamp at each stage, and patient outcome. IV thrombolytics application, pre and post-intervention imaging findings, device related adverse event and any type of intracranial hemorrhage were recorded. Results There was female pre-dominance (54.5%). Median presenting national institutes of health stroke scale (NIHSS) was 16 (IQR, 3–32). 88 MCA-m1 (60,6%), 43 ICA-tip (29,6%), 11 MCA-m2 (7,5%), 2 ACA (1,4%) and 1 basilar (0,7%) occlusions were underwent for mechanical thrombectomy. Median procedure time was 25 min (IQR, 7–136). First-pass reperfusion scores were mTICI 0–2a 22.7%, mTICI 2b 23.4%, mTICI 2c 17.9% and mTICI 3 35.9%. Mean number of pass was 1,84 ± 1,14. Final mTICI 2b-3 score was 97.9% and TICI2c-3 score was 87.6%. No device related adverse event occurred. The mean 24-h NIHSS score was 6 (IQR 0–33). Conclusion In conclusion, the NeVa thrombectomy device offers a high rate of first-pass success along with favorable safety profile. Larger series and multi-center studies are needed for further investigation.

Despite the proven benefit of stent retrievers, challenges to rapid revascularization of large vessel occlusions (LVO) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed with openings in the basket cell structure (“drop zones”) intended to capture organized thrombi within the central scaffold during retrieval. Prospective, multicenter, open label, single arm, FDA-regulated IDE study to evaluate the performance of the NeVa device for recanalizing occluded intracranial vessels including ICA, M1/M2 MCA, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of eTICI 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a margin of -10%. Additional efficacy endpoints included first pass effect to eTICI 2b-3 (FPE) and 90-day mRS 0-2. Primary safety endpoint was 90-day mortality. (ClinicalTrials.gov NCT04514562) (Site-adjudicated revascularization results are reported here. Final core lab results will be presented at the conference.) From April 1, 2021 to April 28, 2022, 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 14 (10%) ICA, 85 (61%) M1, 38 (27%) M2, 1 (1%) Basilar and 1 (1%) PCA. Mean time to first pass was 19 ± 12 minutes. eTICI 2b-3 within 3 NeVa passes occurred in 87.8% (122/139; CI 81.1%,92.7%; non-inferiority p<0.0001; post hoc superiority p=0.002, tested against performance goal of 72%). FPE (to eTICI 2b-3) was observed in 67.6% (94/139), with first pass to eTICI 2b67-3 in 61.2% (85/139) and to eTICI 2c-3 in 43.9% (61/139). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 94.2% (131/139); final eTICI 2c-3 rate was 65.5% (91/139). Good outcome (90-day mRS 0-2) was seen in 62.6% (87/139) and was 74.4% in patients with FPE (70/94 vs. 17/45 (37.8%) without FPE; p<0.0001). Mortality was 9.4% (13/139) with sICH in 8 (5.8%) subjects. The NeVa device is effective and safe for revascularization of LVO strokes and demonstrates high first pass success in this international multicenter study. First pass reperfusion (eTICI 2b-3) was strongly associated with functional independence.

Introduction Occlusive thrombi in acute ischemic stroke can be in various types which limits the success of the thrombectomy.The NeVaTM(Vesalio, Nashville, Tennessee) thrombectomy device was originally designed for all types of clot. Our aim was to evaluate the efficacy and safety of the NeVaTMdevice for mechanical thrombectomy. Methods Retrospective review of prospectively collected mechanical thrombectomy database revealed 145 patients who had fullfilled the inclusion criteria.The data collected includes clinical patient characteristics, procedural measures, timestamp at each stage, and patient outcome. IV thrombolytics application, pre and post‐intervention imaging findings, device related adverse event and any type of intracranial hemorrhage were recorded. Results There was female pre‐dominance (54.5%). Median presenting NIHSS was 16 (IQR, 3–32). 88 MCA‐m1 (60,6%), 43 ICA‐tip (29,6%), 11 MCA‐m2 (7,5%), 2 ACA (1,4%) and 1 basilar (0,7%) occlusions were underwent for mechanical thrombectomy. Median procedure time was 25 min (IQR, 7–136). First‐pass reperfusion scores were mTICI 0–2a 22.7%, mTICI 2b 23.4%, mTICI 2c 17.9% andmTICI 3 35.9%.Mean number of pass was1,84±1,14.Final mTICI 2b‐3 score was 97.9% and TICI2c‐3 score was 87.6%. No device related adverse event occurred. The mean 24‐hour NIHS score was 6 (IQR 0–33). Conclusions In conclusion, the NeVa thrombectomy device offers a high rate of first‐pass success along with favorable safety profile. Larger series and multi‐center studies are needed for further investigation