Clinical trial NCT04195568: Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System
Official title: EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aneurysm, Intracranial
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed description: 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 for treatment in vessel diameters between 1.75-5.0mm.

Eligibility criteria: 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 outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 12 months (± 3 months) post procedure
measure: Primary Safety Endpoint
timeFrame: 12 Months (± 3 months) post procedure
Secondary outcomes:
measure: Secondary Safety Endpoints
timeFrame: 3 Year Follow-Up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: DIGNITY HEALTH/ Barrow Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: St. Joseph's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Jacksonville
country: United States
facility: Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Healthcare System, Inc./Baptist Health
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: North Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: ICAHN School of Medicine at Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Memphis
country: United States
facility: Semmes Murphey Clinic/ University of Tennessee Health Sciences Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Harlingen
country: United States
facility: Valley Baptist Health System, Harlingen
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Perth
city: Southport
country: Australia
facility: Gold Coast Hospital & Health Service/ Gold Coast University Hospital
state: Queensland
city: Toronto
country: Canada
facility: St. Michael's Hospital - Toronto
state: Ontario
city: Toronto
country: Canada
facility: University Health Network/ Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Semmes Murphy Clinic
name: Adam S Arthur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Vitor M Pereira, MD
role: PRINCIPAL_INVESTIGATOR
References: