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

NCT ID: NCT05018650

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2024-05-22

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Route 92 Medical Reperfusion System

Intervention Type: DEVICE

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.

Aspiration Predicate

Aspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke

Group Type: ACTIVE_COMPARATOR

Route 92 Medical Reperfusion System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Route 92 Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guilherme Dabus, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Health - Miami

Ajit Puri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Thanh Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Banner Health

Mesa, Arizona, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Christiana Care

Newark, Delaware, United States

Baptist Jacksonville

Jacksonville, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Advocate Aurora Health

Chicago, Illinois, United States

University of Kansas

Kansas City, Kansas, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Tufts

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Massachusetts

Worcester, Massachusetts, United States

Saint Luke's

Kansas City, Missouri, United States

Cooper Health System

Camden, New Jersey, United States

Rutgers

Piscataway, New Jersey, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio Health

Columbus, Ohio, United States

Wright State University

Dayton, Ohio, United States

Mercy Health St. Vincent

Toledo, Ohio, United States

OHSU

Portland, Oregon, United States

Geisinger Clinic

Danville, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Fort Sanders Medical Center

Knoxville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

Valley Baptist

Harlingen, Texas, United States

Medical City Plano

Plano, Texas, United States

University of Utah

Salt Lake City, Utah, United States

West Virginia University

Morgantown, West Virginia, United States

Auckland City Hospital

Auckland, , New Zealand

Countries

United States; New Zealand

References

Nguyen TN, Dabus G, McGuinness B, Caldwell J, Priest R, Rai AT, Zaidat OO, Gross BA, Hanel R, Lee S, Hussain S, Shaikh H, Abdalkader M, Budzik R, Kilburg C, Woodward K, Colasurdo M, Liu J, Yoo AJ, Khandelwal P, Boo S, Vu P, Lin E, Almajali M, Singh J, Al-Bayati A, Lang MJ, Abraham M, Hassan AE, Pema P, Martin C, Grandhi R, Tonetti DA, Hixson HR, Aghaebrahim A, Sauvageau E, Ortega-Gutierrez S, Yavagal DR, Cheng-Ching E, Khalife J, Linfante I, Vulkanov V, Soomro J, Fifi JT, Maidan L, Copelan A, Schirmer CM, Bain M, Toth G, Jayaraman M, Novakovic-White R, Satti S, Villelli N, Jabbour P, Page M, McAllister DJ, Araujo Contreras R, Samaniego EA, Liebeskind DS, Hetts SW, Nogueira RG, English J, Puri AS. SUMMIT MAX: A Randomized Trial of the Super Large Bore HiPoint Reperfusion System Versus Vecta System for Aspiration Thrombectomy. Stroke. 2025 Aug;56(8):1980-1990. doi: 10.1161/STROKEAHA.125.051742. Epub 2025 May 21.

Reference Type: DERIVED

PMID: 40395106 (View on PubMed)

Other Identifiers

CIP 0974

Identifier Type: -

Identifier Source: org_study_id