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

Completed · Not applicable

Conditions studied: Acute Ischemic Stroke

In brief

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 with the Hi Point 88 and HiPoint 70 Reperfusion Catheters for aspiration thrombectomy in acute ischemic stroke patients.

Key facts

Study ID

NCT05018650

Run by

Route 92 Medical, Inc.

People needed

250

Starts

2021-12-21

Expected to finish

2024-05-22

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner Health — Mesa, Arizona, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• Christiana Care — Newark, Delaware, United States
• Baptist Jacksonville — Jacksonville, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Advocate Aurora Health — Chicago, Illinois, United States
• University of Kansas — Kansas City, Kansas, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Tufts — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Saint Luke's — Kansas City, Missouri, United States
• Cooper Health System — Camden, New Jersey, United States
• Rutgers — Piscataway, New Jersey, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio Health — Columbus, Ohio, United States
• Wright State University — Dayton, Ohio, United States
• Mercy Health St. Vincent — Toledo, Ohio, United States
• OHSU — Portland, Oregon, United States
• Geisinger Clinic — Danville, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Fort Sanders Medical Center — Knoxville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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