A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)

Study Overview
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Brief Summary
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The SUMMIT MAX study is a prospective, randomized, controlled, interventional clinical trial to evaluate the safety and effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for aspiration thrombectomy in acute ischemic stroke patients.

Detailed Description
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The purpose of the SUMMIT MAX study is to obtain the safety and effectiveness data necessary to demonstrate substantial equivalence of the Route 92 Medical Reperfusion System with a predicate aspiration device to support a 510(k) application to the U.S. Food and Drug Administration (FDA) under the classification product code, NRY.

Official Title
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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 (SUMMIT MAX)

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: Route 92 Medical Reperfusion System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The consent process has been completed and documented according to applicable country regulations and as approved by the IRB / Ethics Committee Age >=18 years Patient presenting with 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 Baseline ASPECTS >= 6 Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well If indicated, thrombolytic therapy shall be initiated per clinical guidelines. If eligible for thrombolytic therapy, subjects should be treated as soon as possible and lytic use should not be delayed regardless of potential eligibility for mechanical neurothrombectomy. The patient is indicated for aspiration neurothrombectomy with the Route 92 Medical Reperfusion System as determined by the Investigator Angiographic confirmation of a large vessel occlusion of the M1 segment of the middle cerebral artery or distal internal carotid artery Exclusion Criteria: Known pregnancy or breast feeding In the Investigator's opinion, any known comorbidity (including COVID-19 positivity) that may complicate treatment or prevent improvement or follow-up Known serious, advanced, or terminal illness with anticipated life expectancy < 12 months Known history of severe allergy to contrast medium Known to have suffered a stroke in the past 90 days Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, Ehlers-Danlos syndrome) Any known previous cerebral hemorrhagic event Any known pre-existing coagulation deficiency Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >3.0 Known baseline platelet count <50,000/µL Known baseline blood glucose of <50 mg/dL or >400 mg/dL Known to be participating in another study involving an investigational device or drug Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories. Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh cerebral hemorrhage (the presence of microbleeds is allowed) Baseline CT or MRI showing intracranial tumor (except small meningioma <= 2cm) or significant mass effect with midline shift due to the tumor Presumed septic thrombus, or suspicion of bacterial endocarditis Inability to access the cerebral vasculature in the opinion of the neurointerventional team Unlikely to be available for a 90-day follow-up (e.g. no fixed home address) Evidence of arterial dissection in a vessel that must be traversed Evidence of high-grade stenosis or occlusion (i.e., tandem occlusion) in a vessel that must be traversed Known active or recent history of cocaine or methamphetamine abuse (within last 6 months) Known history or presence of aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion For all patients, severe sustained hypertension with SBP >200 and/or DBP >120; for patients treated with a lytic, sustained hypertension despite treatment with SBP >185 and/or DBP >110 Treatment with heparin within 48 hours with a partial thromboplastic time more than two times the laboratory normal or treatment with any LMWH within 48 hours Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30 Ongoing seizure due to stroke Evidence of active systemic infection Known cancer with metastases Angiographic evidence of a dissection in the extracranial or intracranial cerebral arteries Arterial 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, tandem occlusions) Angiographic evidence of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion Angiographic evidence or suspicion of aortic dissection Angiographic evidence of an aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Route 92 Medical Reperfusion System<br>Aspiration thrombectomy with the Route 92 Reperfusion System to treat acute ischemic stroke | Device: Route 92 Medical Reperfusion System<br>* Mechanical thrombectomy for acute ischemic stroke patients with large vessel occlusions will be performed with direct aspiration consisting of navigating a large-bore catheter up to the face of the clot and initiating vacuum suction.<br>|
| Active Comparator: Aspiration Predicate<br>Aspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke | Device: Route 92 Medical Reperfusion System<br>* Mechanical thrombectomy for acute ischemic stroke patients with large vessel occlusions will be performed with direct aspiration consisting of navigating a large-bore catheter up to the face of the clot and initiating vacuum suction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater | mTICI of 2b or greater indicates successful reperfusion following blood clot removal | During procedure | 
| Incidence of all symptomatic intracerebral hemorrhage (sICH) | Evaluation of sICH per von Kummer et al | within 24 hours post-procedure |