Thrombectomy for Acute Ischemic Stroke With a New Device-Skyflow: Study Protocol for a Prospective, Multicenter, Stratified Randomized, Single-Blinded, Parallel, Positive Controlled, Non-inferiority Clinical Trial

Abstract

Background: Stent retriever thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in anterior circulation. The aim of the trial is to evaluate whether the new thrombectomy device-Skyflow can achieve the same safety and efficacy as Solitaire FR in the treatment.Method: This study is a prospective, multicenter, stratified randomized, single blind, paralleled, positive controlled, non-inferiority clinical trial. The safety and efficacy of vascular recanalization in AIS patients who are treated with either a new thrombectomy device-Skyflow or with Solitaire FR and within 8 h of symptom onset will be compared. A total of 192 patients will be enrolled, each group with 96 patients. The primary endpoint is successful recanalization rate after the operation. The secondary efficacy endpoints are the time from artery puncture to successful recanalization (mTICI 2b-3), NIHSS scores of 24 h (18–36 h), and 7 ± 2 days after the operation, mRS scores, and the rate of patients with mRS 0–2 scores 90 ± 14 days after the operation, and the success rate of instrument operation. The safety endpoints are the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage at 24 h (18–36 h) post-operation, incidence of adverse events (AE) and serious adverse events (SAE), all-cause mortality, and incidence of device defects.Discussion: This trial will provide information on the safety and efficacy of Sky-flow stent retriever in the treatment of AIS patients with anterior circulation LVO. The success of this trial will be the basis for the product to be finally officially listed and applied in China.Trial registration: Registered on 11 March 2018 with Chinese clinical trial registry. Registration number is ChiCTR1800015166.

New device multisegment Mechanical Thrombectomy System for endovascular treatment in acute ischaemic stroke: study protocol for a prospective, multicentre, randomised controlled trial

“…The multisegment MT System exhibits certain unique characteristics compared with the previously used stent retriever. [14][15][16] The multisegment design of the multisegment MT System keeps the stent open in the diameter direction under tension, thus improving the ability to capture and remove the clot. Similarly, the multisegment MT System has a stronger grasping ability for the clot compared with other stent retriever systems.…”

Comparing the efficacy and safety of the Skyflow device with those of the Solitaire FR stent in patients with acute ischemic stroke: a prospective, multicenter, randomized, non-inferiority clinical trial

“…Solitaire FR or Skyflow thrombectomy stent was used for patients with intracranial anterior circulation large vessel occlusion within 8 hours from onset to compare the efficacy and safety of Skyflow over Solitaire FR. The protocol of the trial has been published previously 9…”

Unequal Efficacy of Different Infarct Location in Predicting Futile Recanalization of Patients With Acute Ischemic Stroke

“…Previous relevant studies have not presented a consistent conclusion yet (6)(7)(8), although the majority of them used the Alberta Stroke Program Early CT score (ASPECTS) subregions to mark infarct location. Therefore, in the present study, we retrospectively combined data from two multicenter, prospective RCTs with large sample sizes (Skyflow study, ChiCTR1800015166; Jrecan study, ChiCTR-TOC-17013822), which were concurrently conducted in China (9), to explore the efficacy of different infarct sites in predicting futile recanalization of patients with AIS.…”