Acute Ischemic Stroke Clinical Trial
Official title:
First Prospective, Single-arm, Multicentre Study to Evaluate the Safety and Efficacy of the Overall Thrombectomy System for Stroke: INEDIT, INDEEP and INTERCEPT in Patients With Acute Ischemic Stroke.
First prospective, single-arm, multicentre study to evaluate the safety and efficacy of the overall stroke thrombectomy system: INEDIT, INDEEP and INTERCEPT in patients with acute ischemic stroke.
This is a prospective, multicentre, single-arm and open-label clinical safety and efficacy research. The purpose of the study is to evaluate the safety and efficacy of the three devices designed by iVascular for neurothrombectomy (iNedit, iNdeep and iNtercept) used together as a tool to facilitate the placement of the stent retriever and apply temporary restriction of blood flow in patients who have suffered a stroke and who undergo mechanical thrombectomy due to acute large vessel occlusion (LVO), presented within 8 hours from symptoms onset (the last time the patient was seen well). Being a mechanical thrombectomy the procedure by which the thrombus that occludes a cerebral vessel is accessed. It is accessed through an endovascular catheter, inserted through the femoral artery, for disruption or removal. ;
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