Neuroscience

Recruiting

Baptist Health Lexington

Nicolas Wayne Villelli

Principal Investigator

Sara Calhoun

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Overview

Summit Max: 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
Description

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.

Learn more at clinicaltrials.gov
Eligibility Criteria

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 and <= 85
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) <= 1
Baseline ASPECTS >= 6
Endovascular treatment initiated (defined as time of first angiogram) 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 carotid dissection
Evidence of cervical carotid artery high-grade stenosis or occlusion (i.e., tandem occlusion)
Active or recent history of drug 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 IV tPA, 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
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
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)
Angiographic evidence of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion
Angiographic evidence or suspicion of aortic dissection