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

Acute Ischemic Stroke Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05018650
• Other study ID #: CIP 0974
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 21, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2023
• Source: Route 92 Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Route 92 Medical, Inc.

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of all symptomatic intracerebral hemorrhage (sICH)	Evaluation of sICH per von Kummer et al	within 24 hours post-procedure