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A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients

All genders
person-wave 18-85
Recruiting now
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Principal Investigator: Adel Malek, MD, PhD

The objective of this study is to compare the safety and effectiveness of the Route 92 Medical Reperfusion System to predicate AXS Vecta Aspiration System.

Study details

Inclusion Criteria
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6, mRS ≤ 1, Baseline ASPECTS ≥ 6
  • Angiographic confirmation of a large vessel occlusion of the M1 segment* of the middle cerebral artery or distal internal carotid artery (patency of the cervical ICA to the origin of the ophthalmic artery
Exclusion Criteria
  • Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >3.0
  • Cervical carotid stenosis requiring balloon angioplasty or stenting at the time of the procedure
  • Angiographic evidence of multiple cerebrovascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation), of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion, and Angiographic evidence or suspicion of aortic dissection
Study Requirements

The total duration for study participation required is the standard hospital stay for post-neurothrombectomy treatment for an acute ischemic stroke. For this trial, no additional clinical or laboratory evaluations are required from the standard hospital routine care procedures. A CT/CTA/MRI/MRA will be conducted at the time of admission to the hospital. An additional CT/CTA/MRI/MRA will be conducted at 24 hours after the procedure. This study will involve two follow up visits; one at 7 days after treatment and one 90-120 days after the procedure.

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