Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System

Study Overview
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Brief Summary
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The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Reperfusion System when used to aspirate emboli in acute ischemic stroke patients.

Detailed Description
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The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Reperfusion System when used to aspirate emboli in acute ischemic stroke patients. The study design is an interventional, prospective, single-arm, open label clinical trial.

Official Title
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A Prospective, Single-arm, 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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: Thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The consent process has been completed with the subject, Legally Authorized Representative, or two physician best interest and consent is documented Age >18 years Clinical signs consistent with an acute ischemic stroke Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6 Pre-stroke modified Rankin Score (mRS) <= 2 Acute occlusion of the M1 segment of the middle cerebral artery (MCA), internal carotid artery (ICA), vertebral or basilar arteries confirmed via computed tomography angiography (CTA) and/or magnetic resonance angiography (MRA) The Investigator estimates that at least one delivery of the Route 92 Medical Reperfusion System can be completed within 24 hours of time last known well In the opinion of the Investigator, reperfusion of the ischemic territory will result in clinical benefit Angiographic confirmation of an occlusion of the M1 segment* of the middle cerebral artery, internal carotid artery, vertebral or basilar arteries with a modified Thrombolysis In Cerebral Infarction (mTICI) scale score of 0-1 Exclusion Criteria: Known pregnancy or breast feeding Known comorbidity that may complicate treatment or prevent improvement or follow-up Known life expectancy < 12 months Known history of severe allergy to contrast medium Subject known to have suffered a stroke in the past 90 days Subject participating in another study involving an investigational device or drug. Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, fibromuscular dysplasia, Ehlers-Danlos syndrome) Any known pre-existing hemorrhagic or coagulation deficiency Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage Baseline CT or MRI showing intracranial tumor (except small meningioma) Angiographic evidence of dissection in the extracranial or intracranial arteries Angiographic evidence of carotid dissection Angiographic evidence of multiple vascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation). Note: tandem occlusions may be included at the discretion of the operating physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrombectomy<br>Aspiration of clot with large bore catheter in acute ischemic stroke patients | Device: Thrombectomy<br>* The Route 92 Medical Reperfusion System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid, middle cerebral, basilar and vertebral arteries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | The primary effectiveness endpoint is arterial revascularization as measured by a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater at the end of angiography after all endovascular treatments. | Procedure | 
| Device-related peri-procedural complications | dissection or perforation | Procedure | 
| Symptomatic Intracranial Cerebral Hemorrhage (SICH) | defined as type 2 parenchymal hemorrhage with a deterioration in National Institutes of Health Stroke Scale [NIHSS] score of >=4 points | 24 hour | 
| Embolization to a previously uninvolved territory | Embolization to a previously uninvolved territory | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS score | The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke | 24 hours after treatment | 
| Modified Rankin Score | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or who have other causes of neurological disability | 90 days after treatment | 
| Procedure Time | Total procedure time from insertion of Route 92 Reperfusion System to final angiogram | Procedure | 
| Procedure-Related SAEs | Serious Adverse Events related to the interventional procedure | Procedure |