A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)
- Conditions
- Acute Ischemic Stroke
- Interventions
- Device: Route 92 Medical Reperfusion System
- Registration Number
- NCT05018650
- Lead Sponsor
- Route 92 Medical, Inc.
- Brief 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 with the Hi Point 88 and HiPoint 70 Reperfusion Catheters for aspiration thrombectomy in acute ischemic stroke patients.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspiration Predicate Route 92 Medical Reperfusion System Aspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke Route 92 Medical Monopoint Reperfusion System Route 92 Medical Reperfusion System Aspiration thrombectomy with the Route 92 Medical HiPoint 88 and HiPoint 70 Reperfusion Catheters as part of the Monopoint Reperfusion System to treat acute ischemic stroke
- Primary Outcome Measures
Name Time Method Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater During procedure mTICI of 2b or greater indicates successful reperfusion following blood clot removal
Incidence of all symptomatic intracerebral hemorrhage (sICH) within 24 hours post-procedure Evaluation of sICH per von Kummer et al
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Mercy San Juan Medical Center
🇺🇸Carmichael, California, United States
Tufts
🇺🇸Boston, Massachusetts, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Advocate Aurora Health
🇺🇸Chicago, Illinois, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Ohio Health
🇺🇸Columbus, Ohio, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Medical City Plano
🇺🇸Plano, Texas, United States
Valley Baptist
🇺🇸Harlingen, Texas, United States
Auckland City Hospital
🇳🇿Auckland, New Zealand
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
Baptist Jacksonville
🇺🇸Jacksonville, Florida, United States
Mercy Health St. Vincent
🇺🇸Toledo, Ohio, United States
Wright State University
🇺🇸Dayton, Ohio, United States
Christiana Care
🇺🇸Newark, Delaware, United States
Banner Health
🇺🇸Mesa, Arizona, United States
Fort Sanders Medical Center
🇺🇸Knoxville, Tennessee, United States
Cooper Health System
🇺🇸Camden, New Jersey, United States
Rutgers
🇺🇸Piscataway, New Jersey, United States
Saint Luke's
🇺🇸Kansas City, Missouri, United States
OHSU
🇺🇸Portland, Oregon, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States