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Acute Ischemic StrokeNCT05018650

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

A study testing Route 92 Medical Reperfusion System in people with Acute Ischemic Stroke, run by Route 92 Medical, Inc. at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Route 92 Medical Reperfusion System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
30 sitesin 2 countries
Study dates
21 Dec 2021to 22 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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
  • Presumed septic thrombus, or suspicion of bacterial endocarditis
  • Inability to access the cerebral vasculature in the opinion of the neurointerventional team
  • Unlikely to be available for a 90-day follow-up (e.g. no fixed home address)
  • Evidence of arterial dissection in a vessel that must be traversed
  • Evidence of high-grade stenosis or occlusion (i.e., tandem occlusion) in a vessel that must be traversed
  • Known active or recent history of cocaine or methamphetamine abuse (within last 6 months)
  • Known history or presence of aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion
  • 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
  • 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
  • Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30
  • Ongoing seizure due to stroke
  • Evidence of active systemic infection
  • Known cancer with metastases
  • Angiographic evidence of a dissection in the extracranial or intracranial cerebral arteries
  • Arterial stenosis requiring balloon angioplasty or stenting at the time of the procedure
  • Angiographic evidence of multiple cerebrovascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation, tandem occlusions)
  • Angiographic evidence of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion
  • Angiographic evidence or suspicion of aortic dissection
  • Angiographic evidence of an aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States29 sites

  • Tufts

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Cooper Health System

    Camden, New Jersey, 08103

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Advocate Aurora Health

    Chicago, Illinois, 60657

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio Health

    Columbus, Ohio, 43214

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Geisinger Clinic

    Danville, Pennsylvania, 17822

  • Wright State University

    Dayton, Ohio, 45409

  • Valley Baptist

    Harlingen, Texas, 78550

  • Baptist Jacksonville

    Jacksonville, Florida, 32207

  • University of Kansas

    Kansas City, Kansas, 66160

  • Saint Luke's

    Kansas City, Missouri, 64111

  • Fort Sanders Medical Center

    Knoxville, Tennessee, 37902

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Banner Health

    Mesa, Arizona, 85202

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Christiana Care

    Newark, Delaware, 19718

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Rutgers

    Piscataway, New Jersey, 08854

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • Medical City Plano

    Plano, Texas, 75075

  • OHSU

    Portland, Oregon, 97219

  • University of Utah

    Salt Lake City, Utah, 84123

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Mercy Health St. Vincent

    Toledo, Ohio, 43608

  • University of Massachusetts

    Worcester, Massachusetts, 01655

Other trials in United States

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

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)

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.

Read the 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.

Being tested
Route 92 Medical Reperfusion System
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Route 92 Medical Reperfusion SystemDevice

    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.

Study groups in NCT05018650
Study groupRoleWhat they receive
Route 92 Medical Monopoint Reperfusion SystemExperimentalAspiration 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
Receives: Device: Route 92 Medical Reperfusion System
Aspiration PredicateActive comparatorAspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke
Receives: Device: Route 92 Medical Reperfusion System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During procedure

  2. Incidence of all symptomatic intracerebral hemorrhage (sICH)

    Evaluation of sICH per von Kummer et al

    Measured: within 24 hours post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start21 Dec 2021
  3. Primary completion19 Feb 2024
  4. Study completion22 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05018650
Sponsor's protocol ID
CIP 0974
Status last verified
Apr 2025
First submitted
18 Aug 2021
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 40395106

Questions about this trial

What is this clinical trial studying?

A study testing Route 92 Medical Reperfusion System in people with Acute Ischemic Stroke, run by Route 92 Medical, Inc. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05018650, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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