Abstract Number ‐ 172: First‐in‐Human Experience: Route 92 Medical 132 cm FreeClimb 88 Catheter for Anterior Circulation LVOs

Abstract

Introduction Direct aspiration thrombectomy of proximal anterior circulation large vessel occlusions (LVOs) with super‐bore catheters (SBCs, 0.088” ID) may result in improved first pass success, though their consistent delivery to the target occlusion remains challenging. We report the first‐in‐human experience with a novel full‐length 132 cm 0.088” ID FreeClimb ® 88 catheter (Route 92 Medical, San Mateo, CA, currently approved for neurovascular access), and its customized Tenzing ® 8 delivery catheter, for anterior circulation LVO acute stroke patients. Methods We performed a retrospective review of thrombectomy cases for proximal anterior circulation large vessel occlusions performed at three stroke centers from May 2022 through August 2022. All patients were treated using the Route 92 Medical 8F Base Camp® guide catheter, FreeClimb ® 88 catheter and Tenzing ® 8 delivery catheter in an off‐label fashion. Results Ten consecutive acute stroke patients with anterior circulation LVOs were treated. The median age was 71 (45‐91) and 6 were female (60%). The median presenting NIHSS score and ASPECT score were 17 (8‐24) and 9 (6‐10), respectively. LVO locations were as follows: two right carotid termini, three right M1 middle cerebral arteries, and five left M1 middle cerebral arteries. Three patients also had tandem occlusion/near‐occlusion of the respective cervical internal carotid artery. The FC88 catheter was delivered to the target occlusion with 100% success. The median time from groin puncture to catheter delivery to the target occlusion was 14 minutes (7‐35). First pass complete reperfusion (modified Thrombolysis in Cerebral Infarction score, mTICI, of 3) was achieved in 9/10 (90%) patients (self‐adjudicated). Adjunctive therapy for a residual M2 occlusion was utilized in 1/10 patients. There were no adverse events or post‐procedural symptomatic hemorrhages. Conclusions Our first‐in‐human experience with a novel 132 cm full‐length super‐bore catheter (Route 92 FreeClimb ® 88 catheter) and its customized catheter delivery device (Tenzing ® 8) for aspiration thrombectomy of proximal anterior circulation large vessel occlusions demonstrated 100% successful delivery to the target occlusion, with TICI 3 first pass reperfusion achieved in 90% of patients.