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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05018650
Recruitment Status : Active, not recruiting
First Posted : August 24, 2021
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Route 92 Medical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: Route 92 Medical Reperfusion System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 21, 2021
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater [ Time Frame: During procedure ]
    mTICI of 2b or greater indicates successful reperfusion following blood clot removal

  2. Incidence of all symptomatic intracerebral hemorrhage (sICH) [ Time Frame: within 24 hours post-procedure ]
    Evaluation of sICH per von Kummer et al


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05018650


Locations
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Sponsors and Collaborators
Route 92 Medical, Inc.
Investigators
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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
More Information
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Responsible Party: Route 92 Medical, Inc.
ClinicalTrials.gov Identifier: NCT05018650    
Other Study ID Numbers: CIP 0974
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Ischemic Stroke
Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases