005 - Safety and Performance of Aspiration Thrombectomy for Lower Extremity Acute Limb Ischemia: STRIDE Interim Analysis
Thomas Maldonado, MD – Vascular Surgeon, NYU Langone Health; Khanjan Nagarsheth, MD – Vascular Surgeon, University of Mayland; Jarrad Rowse, MD – Vascular Surgeon, Cleveland Clinic; Jayer Chung, MD – Vascular Surgeon, Baylor College of Medicine
Purpose: In a recent meta-analysis, the reported rate of 30-day limb salvage in patients with acute limb ischemia (ALI) following surgical intervention was 83.1%.1 The purpose of this interim analysis is to report safety and performance data from STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo® Aspiration System) and to evaluate the benefits of thromboaspiration in the setting of lower extremity (LE) ALI.
Material and Methods: STRIDE is a global prospective, real-world, post-market, multi-center study that will enroll up to 130 participants presenting with LE ALI treated frontline with mechanical thrombectomy using the Indigo Aspiration System prior to stenting or angioplasty. The primary endpoint is target limb salvage rate at 30 days post-procedure. Peri-procedural secondary endpoints included technical success defined as flow restoration (core-lab adjudicated TIMI 2/3 flow) rate immediate post-procedure, change in modified SVS runoff score, major bleeding and device-related SAEs.
Results: Of the 96 participants enrolled from 14 sites, mean age was 65.9 years (46.9% female). Ischemic severity at baseline (n=95) was classified as Rutherford I in 5.3%, Rutherford IIa in 57.9%, and Rutherford IIb in 36.8%. Mean target thrombus length was 109.9±115.8mm. Prior to the procedure, 94.5% (69/73) of patients had no flow (TIMI 0) through the target lesion. The most common thrombus location was the popliteal in 66.0% (62/94) of patients, followed by the superficial femoral in 44.7% (42/94).
Conclusions: This interim analysis of STRIDE study patients demonstrated high rates of technical success and limb salvage, and low rates of periprocedural complications. Based on these results, mechanical aspiration thrombectomy provided a powerful endovascular treatment option for LE ALI patients.