Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System
NCT ID: NCT04195568
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
248 participants
INTERVENTIONAL
2020-07-07
2028-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surpass Evolve Flow Diverter System
This is a prospective single arm study in which all subjects who present for flow diverter implantation, provide informed consent, and meet inclusion/exclusion criteria may receive treatment (Surpass Evolve Flow Diverter).
Surpass Evolve Flow Diverter System
The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤12 mm.
Interventions
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Surpass Evolve Flow Diverter System
The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤12 mm.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Stryker Neurovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Adam S Arthur, MD
Role: PRINCIPAL_INVESTIGATOR
Semmes Murphy Clinic
Vitor M Pereira, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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DIGNITY HEALTH/ Barrow Neurological Institute
Phoenix, Arizona, United States
St. Joseph's Hospital
Tucson, Arizona, United States
University of California, Los Angeles
Los Angeles, California, United States
Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery
Jacksonville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Baptist Healthcare System, Inc./Baptist Health
Lexington, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
University of Massachusetts
North Worcester, Massachusetts, United States
Spectrum Health
Grand Rapids, Michigan, United States
Robert Wood Johnson University Medical Center
New Brunswick, New Jersey, United States
University of Buffalo
Buffalo, New York, United States
ICAHN School of Medicine at Mount Sinai
New York, New York, United States
Stony Brook
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Geisinger Clinic
Wilkes-Barre, Pennsylvania, United States
Semmes Murphey Clinic/ University of Tennessee Health Sciences Center
Memphis, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Valley Baptist Health System, Harlingen
Harlingen, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Sir Charles Gairdner Hospital
Nedlands, Perth, Australia
Gold Coast Hospital & Health Service/ Gold Coast University Hospital
Southport, Queensland, Australia
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
University Health Network/ Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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CDM10001444
Identifier Type: -
Identifier Source: org_study_id
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