Mesh tube could seal dangerous brain aneurysms without surgery

NCT ID NCT04195568

Disease control Sponsor: Stryker Neurovascular Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tests a device called the Surpass Evolve Flow Diverter, a small mesh tube placed inside an artery to redirect blood flow away from a brain aneurysm. The goal is to safely close the aneurysm and prevent it from rupturing. About 248 adults with unruptured, wide-neck aneurysms up to 12 mm in size are being followed for 12 months to see if the device works and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Surpass Evolve Flow Diverter System (a mesh tube placed in the artery to redirect blood flow away from the aneurysm)
What this could lead to: If successful, this device could offer a safer, less invasive way to treat wide-neck brain aneurysms, potentially reducing the need for open surgery or lifelong medication.
What could go wrong: This is a single-arm study without a comparison group, so results may not prove superiority over existing treatments. Risks include stroke, incomplete aneurysm closure, or device-related complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

248 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age is ≥ 18 and ≤ 80 years 2. Has a single unruptured target intracranial aneurysm (IA) with the following characteristics: 1. Is located on the internal carotid artery (ICA) or its branches. 2. Has a neck ≥ 4 mm, dome to neck ratio ≤ 2.0, or no discernible neck 3. Aneurysm size is ≤ 12 mm (saccular or fusiform configuration) 3. Has a parent vessel diameter ≥ 1.75 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed 4. Has multiple increased risk factors for intracranial (IA) aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated. Exclusion Criteria: 1. Has an extradural target aneurysm 2. Has a target aneurysm in the posterior circulation 3. Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from study) 4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation 5. Target aneurysm is unsuitable for flow diverter treatment 6. Has vessel characteristics, such as severe tortuosity (cICA Type IV), stenosis (\>70%), or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device 7. Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device 8. Has a medical contraindication to study or procedure related antiplatelet medications (aspirin, clopidogrel/Plavix, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye 9. Has a known severe allergy to nickel, chromium cobalt, tungsten or platinum. 10. Modified Rankin Score (mRS) assessment is ≥ 3 at preprocedure exam 11. Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days) 12. Subarachnoid hemorrhage occurred within 30 days prior to enrollment 13. Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after enrollment date 14. Has more than one IA that requires treatment within 12 months 15. Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date 16. Chronic anticoagulation therapy is ongoing or known coagulopathy exists 17. Has other known serious concurrent medical conditions such as heart disease (e.g., unstable atrial fibrillation \[with or without pacemaker\], recent myocardial infarction \[\< 12 weeks ago\], symptomatic congestive heart failure, or carotid stenosis), kidney failure \[\>2.0mg/dl serum creatinine\], pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, terminal cancer, vasculitis, high risk of ischemic stroke or recent stroke 18. Has acute life-threatening illness other than the neurological disease (e.g., acute kidney or heart failure) to be treated in this trial 19. Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm) 20. Unable to complete study follow up due to dementia or psychiatric problem, substance abuse, or history of noncompliance with medical advice 21. Pregnancy at time of enrollment 22. Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm 23. Evidence of active infection at the time of treatment 24. Enrollment in another trial involving an investigational product that could confound the outcomes of this trial

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysm, intracranial

Contacts and locations

Locations

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States
Baptist Healthcare System, Inc./Baptist Health

Lexington, Kentucky, 40503, United States
Baptist Hospital of Miami

Miami, Florida, 33176, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
DIGNITY HEALTH/ Barrow Neurological Institute

Phoenix, Arizona, 85013, United States
Geisinger Clinic

Wilkes-Barre, Pennsylvania, 17822, United States
Gold Coast Hospital & Health Service/ Gold Coast University Hospital

Southport, Queensland, 4215, Australia
ICAHN School of Medicine at Mount Sinai

New York, New York, 10029, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Lahey Clinic

Burlington, Massachusetts, 01805, United States
Liverpool Hospital

Liverpool, New South Wales, NSW 2170, Australia
Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States
Maine Medical Center

Portland, Maine, 04102, United States
Mayo Clinic Florida

Jacksonville, Florida, 32224, United States
Montefiore Medical Center

The Bronx, New York, 77555, United States
Oregon Health & Science University

Portland, Oregon, 97239, United States
Robert Wood Johnson University Medical Center

New Brunswick, New Jersey, 08901, United States
Semmes Murphey Clinic/ University of Tennessee Health Sciences Center

Memphis, Tennessee, 38120, United States
Sir Charles Gairdner Hospital

Nedlands, Perth, 2170, Australia
Spectrum Health

Grand Rapids, Michigan, 49503, United States
St. Joseph's Hospital

Tucson, Arizona, 85711, United States
St. Michael's Hospital - Toronto

Toronto, Ontario, M5B 1W8, Canada
Stony Brook

Stony Brook, New York, 11794, United States
Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
University Health Network/ Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada
University of Buffalo

Buffalo, New York, 14203, United States
University of California, Los Angeles

Los Angeles, California, 90095, United States
University of Iowa

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Massachusetts

North Worcester, Massachusetts, 01655, United States
University of Texas Medical Branch

Galveston, Texas, 77555, United States
University of Utah

Salt Lake City, Utah, 84134, United States
Valley Baptist Health System, Harlingen

Harlingen, Texas, 78550, United States
Virginia Commonwealth University

Richmond, Virginia, 23298, United States

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