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

NCT05018650 | Completed DMC FDA Device

• 1 other identifier: CIP 0974
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 30

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Route 92 Medical Monopoint Reperfusion System

EXPERIMENTAL

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

Aspiration Predicate

ACTIVE COMPARATOR

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

Device: Route 92 Medical Reperfusion System

Interventions

Route 92 Medical Reperfusion System 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; Route 92 Medical Monopoint Reperfusion System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known pregnancy or breast feeding
• In the Investigator's opinion, any known comorbidity (including COVID-19 positivity) that may complicate treatment or prevent improvement or follow-up
• Known serious, advanced, or terminal illness with anticipated life expectancy \< 12 months
• Known history of severe allergy to contrast medium
• Known to have suffered a stroke in the past 90 days
• Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, Ehlers-Danlos syndrome)
• Any known previous cerebral hemorrhagic event
• Any known pre-existing coagulation deficiency
• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>3.0
• Known baseline platelet count \<50,000/µL
• Known baseline blood glucose of \<50 mg/dL or \>400 mg/dL
• Known to be participating in another study involving an investigational device or drug
• Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh cerebral hemorrhage (the presence of microbleeds is allowed)
• Baseline CT or MRI showing intracranial tumor (except small meningioma \<= 2cm) or significant mass effect with midline shift due to the tumor

Sponsors & Collaborators

• Route 92 Medical, Inc.: lead

Study Sites (30)

Banner Health

Mesa, Arizona, 85202, United States

Location

Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

Christiana Care

Newark, Delaware, 19718, United States

Location

Baptist Jacksonville

Jacksonville, Florida, 32207, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Advocate Aurora Health

Chicago, Illinois, 60657, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Tufts

Boston, Massachusetts, 02111, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Saint Luke's

Kansas City, Missouri, 64111, United States

Location

Cooper Health System

Camden, New Jersey, 08103, United States

Location

Rutgers

Piscataway, New Jersey, 08854, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Health

Columbus, Ohio, 43214, United States

Location

Wright State University

Dayton, Ohio, 45409, United States

Location

Mercy Health St. Vincent

Toledo, Ohio, 43608, United States

Location

OHSU

Portland, Oregon, 97219, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Fort Sanders Medical Center

Knoxville, Tennessee, 37902, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Valley Baptist

Harlingen, Texas, 78550, United States

Location

Medical City Plano

Plano, Texas, 75075, United States

Location

University of Utah

Salt Lake City, Utah, 84123, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 40395106 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guilherme Dabus, MD

  Baptist Health - Miami

  PRINCIPAL INVESTIGATOR

• Ajit Puri, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

• Thanh Nguyen, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: December 21, 2021
• Primary Completion: February 19, 2024
• Study Completion: May 22, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); US (29)