Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA)

Abstract

Background: The Advanced Neurovascular Access (ANA) thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, the ANA device allows distal aspiration combined with a stent retriever to mobilize the clot into the funnel where it remains copped during extraction. We investigated the safety and efficacy of ANA catheter system. Methods: SOLONDA (Solitaire in Combination With the ANA Catheter System as Manufactured by Anaconda) was a prospective, open, single-arm, multicenter trial with blinded assessment of the primary outcome by an independent core lab. Patients with anterior circulation vessel occlusion admitted within 8 hours from symptom onset were eligible. The primary end point was successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b–3) with ≤3 passes of the ANA device in combination with stent retriever, before the use of rescue therapy in the intention to treat population. Primary predefined analysis was noninferiority as compared to the performance end point observed in HERMES (High Effective Reperfusion Using Multiple Endovascular Devices). Results: After enrollment of 74 patients, an interim analysis was conducted, and the trial Steering Committee decided to terminate recruitment due to safety and performance objectives were reached. Mean age was 71.6 (SD 8.9) years, 46.6% women and median National Institutes of Health Stroke Scale on admission 14 (interquartile range, 10–19). Successful reperfusion within 3 passes before rescue therapy was achieved in 60/72 (83.3% [95% CI, 74.7%–91.9%]) with a rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 2c–3) of 60% (95% CI, 48.4%–71.1%; 43/72 patients). After noninferiority was confirmed ( P <0.01), the ANA device also showed superiority in the rate of successful reperfusion with ≤3 passes ( P =0.02). First-pass successful recanalization rate was 55.6% (95% CI, 44.1%–67.0%), with a first-pass complete recanalization rate of 38.9% (95% CI, 27.6%–50.1%). Rescue therapy to obtain a modified Thrombolysis in Cerebral Infarction score 2b–3 was needed in 12/72 (17%) patients. At 90 days, the rate of favorable functional outcome (modified Rankin Scale score 0–2) was 57.5% (95% CI, 46.2%–68.9%), and the rate of excellent functional outcome (modified Rankin Scale score 0–1) was 45.2% (95% CI, 33.8%–56.6%). The rate of severe adverse device related was 1.4%. Conclusions: In this clinical experience, the ANA device achieved a high rate of complete recanalization with a preliminary good safety profile and favorable 90 days clinical outcomes.

Impact of stent-retriever tip design on distal embolization during mechanical thrombectomy: a randomized in vitro evaluation

“…Our experimental setup has certain shortcomings when it comes to replicating device–clot–vessel wall interactions, the heterogeneity of clots, and the hemodynamic conditions. However, the FPR rate data from clinical trials (30–60%)6 27 suggests that our setup is capable of providing a fair simulation of real-world cases. Nevertheless, the outcomes might have differed if other MT techniques instead of SR combined with BGC, or clot analogs with different mechanical characteristics, were used.…”

“…Recent developments in thrombectomy devices aimed to improve the FPR rate and minimize the incidence of distal and new territory embolization. Device features such as flow control,4 the catheter to the vessel ratio,5 6 the diameter and length of the SR,7 the radial force, and the open architectures of the SRs8 9 have been shown to contribute to the degree of achievement of these procedural endpoints.…”