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

EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System

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

Study Overview

• Status: Active, not recruiting
• Conditions: Aneurysm, Intracranial
• Intervention / Treatment: Device: Surpass Evolve Flow Diverter System

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.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, NSW 2170
      • Liverpool Hospital
  • Perth
    • Nedlands, Perth, Australia, 2170
      • Sir Charles Gairdner Hospital
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Gold Coast Hospital & Health Service/ Gold Coast University Hospital
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital - Toronto
    • Toronto, Ontario, Canada, M5T 2S8
      • University Health Network/ Toronto Western Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • DIGNITY HEALTH/ Barrow Neurological Institute
    • Tucson, Arizona, United States, 85711
      • St. Joseph's Hospital
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
    • Jacksonville, Florida, United States, 32207
      • Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Healthcare System, Inc./Baptist Health
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
    • North Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Medical Center
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai
    • Stony Brook, New York, United States, 11794
      • Stony Brook
    • The Bronx, New York, United States, 77555
      • Montefiore Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Wilkes-Barre, Pennsylvania, United States, 17822
      • Geisinger Clinic
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Semmes Murphey Clinic/ University of Tennessee Health Sciences Center
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Harlingen, Texas, United States, 78550
      • Valley Baptist Health System, Harlingen
  • Utah
    • Salt Lake City, Utah, United States, 84134
      • University of Utah
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	The primary effectiveness endpoint of this study is a composite of 100% occlusion (Raymond 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (>50% stenosis), per independent core lab assessment of digital subtraction angiography (DSA) images acquired at 12 months (± 3 months) post-procedure, and with no target aneurysm retreatment.	12 months (± 3 months) post procedure
Primary Safety Endpoint	The primary safety endpoint of this study is neurologic death, or disabling stroke at 12 months as adjudicated by an independent Clinical Events Committee (CEC).	12 Months (± 3 months) post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoints	The secondary safety endpoints will be evaluated throughout the study, and are as follows: Neurological death or major ipsilateral stroke as adjudicated by an independent Clinical Events Committee.; Stroke in the treated vascular territory as adjudicated by a Clinical Events Committee	3 Year Follow-Up

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Adam S Arthur, MD, Semmes Murphy Clinic; Principal Investigator: Vitor M Pereira, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): July 14, 2025
• Study Completion (Estimated): September 13, 2028

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Calcium Carbonate
• Other Study ID Numbers: CDM10001444

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No