Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System

Running, not enrolling · Not applicable

Conditions studied: Aneurysm, Intracranial

In brief

The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches

Key facts

Study ID

NCT04195568

Run by

Stryker Neurovascular

People needed

248

Starts

2020-07-07

Expected to finish

2028-09-13

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age is ≥ 18 and ≤ 80 years
• Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:
• Is located on the internal carotid artery (ICA) or its branches.
• Has a neck ≥ 4 mm, dome to neck ratio ≤ 2.0, or no discernible neck
• Aneurysm size is ≤ 12 mm (saccular or fusiform configuration)
• 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
• 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.

You may not qualify if…

• Has an extradural target aneurysm
• Has a target aneurysm in the posterior circulation
• 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)
• Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
• Target aneurysm is unsuitable for flow diverter treatment
• 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
• Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
• 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
• Has a known severe allergy to nickel, chromium cobalt, tungsten or platinum.
• Modified Rankin Score (mRS) assessment is ≥ 3 at preprocedure exam
• Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
• Subarachnoid hemorrhage occurred within 30 days prior to enrollment
• Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after enrollment date
• Has more than one IA that requires treatment within 12 months
• Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
• Chronic anticoagulation therapy is ongoing or known coagulopathy exists
• 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
• Has acute life-threatening illness other than the neurological disease (e.g., acute kidney or heart failure) to be treated in this trial
• Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
• Unable to complete study follow up due to dementia or psychiatric problem, substance abuse, or history of noncompliance with medical advice
• Pregnancy at time of enrollment
• Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
• Evidence of active infection at the time of treatment
• Enrollment in another trial involving an investigational product that could confound the outcomes of this trial

Where it is running

• 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

Full record on ClinicalTrials.gov

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