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

NCT04195568 | Active Not Recruiting FDA Device

• 1 other identifier: CDM10001444
• Study Type: interventional
• Target: 248
• Locations: 3 countries
• Sites: 37

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

Conditions

Aneurysm, Intracranial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Secondary Safety Endpoints

  3 Year Follow-Up

Study Arms (1)

Surpass Evolve Flow Diverter System

EXPERIMENTAL

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

Interventions

Surpass Evolve Flow Diverter System DEVICE

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.

Surpass Evolve Flow Diverter System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (37)

DIGNITY HEALTH/ Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

St. Joseph's Hospital

Tucson, Arizona, 85711, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Baptist Healthcare System, Inc./Baptist Health

Lexington, Kentucky, 40503, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts

North Worcester, Massachusetts, 01655, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Robert Wood Johnson University Medical Center

New Brunswick, New Jersey, 08901, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

ICAHN School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Stony Brook

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center

The Bronx, New York, 77555, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Geisinger Clinic

Wilkes-Barre, Pennsylvania, 17822, United States

Location

Semmes Murphey Clinic/ University of Tennessee Health Sciences Center

Memphis, Tennessee, 38120, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Valley Baptist Health System, Harlingen

Harlingen, Texas, 78550, United States

Location

University of Utah

Salt Lake City, Utah, 84134, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Liverpool Hospital

Liverpool, New South Wales, NSW 2170, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Perth, 2170, Australia

Location

Gold Coast Hospital & Health Service/ Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

St. Michael's Hospital - Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network/ Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adam S Arthur, MD

  Semmes Murphy Clinic

  PRINCIPAL INVESTIGATOR

• Vitor M Pereira, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 12, 2019
• Study Start: July 7, 2020
• Primary Completion: July 14, 2025
• Study Completion (Estimated): September 13, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (32); AU (3); CA (2)