A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (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 Embolectomy in Acute Ischemic Stroke Patients (SUMMIT MAX)

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Route 92 Medical Reperfusion System

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Banner Health
  • California
    • Carmichael, California, United States, 95608
      • Mercy San Juan Medical Center
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Jacksonville
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Advocate Aurora Health
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Health System
    • Piscataway, New Jersey, United States, 08854
      • Rutgers
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214
      • Ohio Health
    • Dayton, Ohio, United States, 45409
      • Wright State University
    • Toledo, Ohio, United States, 43608
      • Mercy Health St. Vincent
  • Oregon
    • Portland, Oregon, United States, 97219
      • OHSU
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Clinic
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
  • Tennessee
    • Knoxville, Tennessee, United States, 37902
      • Fort Sanders Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Harlingen, Texas, United States, 78550
      • Valley Baptist
    • Plano, Texas, United States, 75075
      • Medical City Plano
  • Utah
    • Salt Lake City, Utah, United States, 84123
      • University of Utah
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The consent process has been completed and documented according to applicable country regulations and as approved by the IRB / Ethics Committee
2. Age >=18 years
3. Patient presenting with clinical signs consistent with an acute ischemic stroke
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
5. Pre-stroke modified Rankin Score (mRS) <= 2
6. Baseline ASPECTS >= 6
7. Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well
8. 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.
9. The patient is indicated for aspiration neurothrombectomy with the Route 92 Medical Reperfusion System as determined by the Investigator
10. Angiographic confirmation of a large vessel occlusion of the M1 segment of the middle cerebral artery or distal internal carotid artery

Exclusion Criteria:

1. Known pregnancy or breast feeding
2. In the Investigator's opinion, any known comorbidity (including COVID-19 positivity) that may complicate treatment or prevent improvement or follow-up
3. Known serious, advanced, or terminal illness with anticipated life expectancy < 12 months
4. Known history of severe allergy to contrast medium
5. Known to have suffered a stroke in the past 90 days
6. Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, Ehlers-Danlos syndrome)
7. Any known previous cerebral hemorrhagic event
8. Any known pre-existing coagulation deficiency
9. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >3.0
10. Known baseline platelet count <50,000/µL
11. Known baseline blood glucose of <50 mg/dL or >400 mg/dL
12. Known to be participating in another study involving an investigational device or drug
13. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
14. Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh cerebral hemorrhage (the presence of microbleeds is allowed)
15. Baseline CT or MRI showing intracranial tumor (except small meningioma <= 2cm) or significant mass effect with midline shift due to the tumor
16. Presumed septic thrombus, or suspicion of bacterial endocarditis
17. Inability to access the cerebral vasculature in the opinion of the neurointerventional team
18. Unlikely to be available for a 90-day follow-up (e.g. no fixed home address)
19. Evidence of arterial dissection in a vessel that must be traversed
20. Evidence of high-grade stenosis or occlusion (i.e., tandem occlusion) in a vessel that must be traversed
21. Known active or recent history of cocaine or methamphetamine abuse (within last 6 months)
22. Known history or presence of aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion
23. 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
24. 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
25. Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30
26. Ongoing seizure due to stroke
27. Evidence of active systemic infection
28. Known cancer with metastases
29. Angiographic evidence of a dissection in the extracranial or intracranial cerebral arteries
30. Arterial stenosis requiring balloon angioplasty or stenting at the time of the procedure
31. Angiographic evidence of multiple cerebrovascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation, tandem occlusions)
32. Angiographic evidence of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion
33. Angiographic evidence or suspicion of aortic dissection
34. Angiographic evidence of an aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspiration Predicate; Aspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke	Device: Route 92 Medical Reperfusion System; 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.
Experimental: Route 92 Medical Monopoint 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	Device: Route 92 Medical Reperfusion System; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Route 92 Medical, Inc.
• Investigators: Principal Investigator: Guilherme Dabus, MD, Baptist Health - Miami; Principal Investigator: Ajit Puri, MD, University of Massachusetts, Worcester; Principal Investigator: Thanh Nguyen, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): February 19, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CIP 0974

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes