Clinical trial NCT05018650: A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Route 92 Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater
timeFrame: During procedure
measure: Incidence of all symptomatic intracerebral hemorrhage (sICH)
timeFrame: within 24 hours post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Health
state: Arizona
city: Carmichael
country: United States
facility: Mercy San Juan Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Jacksonville
country: United States
facility: Baptist Jacksonville
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Chicago
country: United States
facility: Advocate Aurora Health
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Boston
country: United States
facility: Tufts
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Kansas City
country: United States
facility: Saint Luke's
state: Missouri
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: Piscataway
country: United States
facility: Rutgers
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio Health
state: Ohio
city: Dayton
country: United States
facility: Wright State University
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St. Vincent
state: Ohio
city: Portland
country: United States
facility: OHSU
state: Oregon
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Knoxville
country: United States
facility: Fort Sanders Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Harlingen
country: United States
facility: Valley Baptist
state: Texas
city: Plano
country: United States
facility: Medical City Plano
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Baptist Health - Miami
name: Guilherme Dabus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Ajit Puri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Thanh Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: