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Clinical Trials in Australia / NCT04195568
Active, not recruiting Not applicable

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

NCT04195568 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2020-07-07
Last updated
2026-08-17

Condition(s) studied

Aneurysm, Intracranial

Investigational drug(s) / intervention(s)

Surpass Evolve Flow Diverter System

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
DIGNITY HEALTH/ Barrow Neurological Institute Phoenix Arizona
St. Joseph's Hospital Tucson Arizona
University of California, Los Angeles Los Angeles California
Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery Jacksonville Florida
Mayo Clinic Florida Jacksonville Florida
Baptist Hospital of Miami Miami Florida
Tallahassee Neurological Clinic Tallahassee Florida
Advocate Lutheran General Hospital Park Ridge Illinois
Indiana University Indianapolis Indiana
University of Iowa Iowa City Iowa
University of Kansas Medical Center Kansas City Kansas
Baptist Healthcare System, Inc./Baptist Health Lexington Kentucky
Maine Medical Center Portland Maine
Tufts Medical Center Boston Massachusetts
Beth Israel Deaconess Medical Center Boston Massachusetts
Lahey Clinic Burlington Massachusetts
University of Massachusetts North Worcester Massachusetts
Spectrum Health Grand Rapids Michigan
Robert Wood Johnson University Medical Center New Brunswick New Jersey
University of Buffalo Buffalo New York
ICAHN School of Medicine at Mount Sinai New York New York
Stony Brook Stony Brook New York
Montefiore Medical Center The Bronx New York
Cleveland Clinic Cleveland Ohio
Oregon Health & Science University Portland Oregon
Thomas Jefferson University Philadelphia Pennsylvania
Geisinger Clinic Wilkes-Barre Pennsylvania
Semmes Murphey Clinic/ University of Tennessee Health Sciences Center Memphis Tennessee
University of Texas Medical Branch Galveston Texas
Valley Baptist Health System, Harlingen Harlingen Texas
University of Utah Salt Lake City Utah
Virginia Commonwealth University Richmond Virginia
Liverpool Hospital Liverpool New South Wales
Sir Charles Gairdner Hospital Nedlands Perth
Gold Coast Hospital & Health Service/ Gold Coast University Hospital Southport Queensland
St. Michael's Hospital - Toronto Toronto Ontario
University Health Network/ Toronto Western Hospital Toronto Ontario
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04195568 on ClinicalTrials.gov ↗ ← All trials in Australia