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

Last updated: November 29, 2022
Sponsor: Route 92 Medical, Inc.
Overall Status: Active - Recruiting







Clinical Study ID

CIP 0974
  • Ages 18-85
  • All Genders

Study Summary

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.

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

Study Design

Study Start date:
Estimated Completion Date:

Study Description

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.

Connect with a study center

  • Baptist Healthcare System

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.