| Authors |
Yoo, Albert J ; Geyik, Serdar ; Froehler, Michael T ; Maurer, Christoph Johannes ; Kass-Hout, Tareq ; Zaidat, Osama O ; Nogueira, Raul G ; Hanel, Ricardo A ; Pierot, Laurent ; Spelle, Laurent ; Lopes, Demetrius ; Hassan, Ameer ; Širvinskas, Audrius ; Lin, Eugene ; Ribo, Marc ; Blasco, Jordi ; Taqi, Muhammad Asif ; Badruddin, Aamir ; Siddiqui, Adnan H ; Miller, Timothy R ; Hussain, Shazam M ; Haussen, Diogo C ; Woodward, Keith ; Groden, Christoph ; Consoli, Arturo ; Chaudry, M Imran ; Ramsey, Christian ; Maud, Alberto ; Bentley, Joshua ; Bajrami, Arsida ; Sahnoun, Maher ; Fiehler, Jens ; Gupta, Rishi |
| Abstract [eng] |
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. |
