Aneurysm, IntracranialEVOLVENCT04195568
Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System
A study testing Surpass Evolve Flow Diverter System in people with Aneurysm, Intracranial, run by Stryker Neurovascular at 37 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysm, Intracranial
- What is being tested?
- Surpass Evolve Flow Diverter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 37 sitesin 3 countries
- Study dates
- 7 Jul 2020to 13 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
37 sites in 3 countries.
37 sites in 3 countries
United States32 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Buffalo
Buffalo, New York, 14203
Lahey Clinic
Burlington, Massachusetts, 01805
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Medical Branch
Galveston, Texas, 77555
Spectrum Health
Grand Rapids, Michigan, 49503
Valley Baptist Health System, Harlingen
Harlingen, Texas, 78550
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery
Jacksonville, Florida, 32207
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
Baptist Healthcare System, Inc./Baptist Health
Lexington, Kentucky, 40503
University of California, Los Angeles
Los Angeles, California, 90095
Semmes Murphey Clinic/ University of Tennessee Health Sciences Center
Memphis, Tennessee, 38120
Baptist Hospital of Miami
Miami, Florida, 33176
Robert Wood Johnson University Medical Center
New Brunswick, New Jersey, 08901
ICAHN School of Medicine at Mount Sinai
New York, New York, 10029
University of Massachusetts
North Worcester, Massachusetts, 01655
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
DIGNITY HEALTH/ Barrow Neurological Institute
Phoenix, Arizona, 85013
Maine Medical Center
Portland, Maine, 04102
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Utah
Salt Lake City, Utah, 84134
Stony Brook
Stony Brook, New York, 11794
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
Montefiore Medical Center
The Bronx, New York, 77555
St. Joseph's Hospital
Tucson, Arizona, 85711
Geisinger Clinic
Wilkes-Barre, Pennsylvania, 17822
Australia3 sites
Liverpool Hospital
Liverpool, New South Wales, NSW 2170
Sir Charles Gairdner Hospital
Nedlands, Perth, 2170
Gold Coast Hospital & Health Service/ Gold Coast University Hospital
Southport, Queensland, 4215
Canada2 sites
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
University Health Network/ Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: 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
Read the 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.
- Conditions
- Aneurysm, Intracranial
- Being tested
- Surpass Evolve Flow Diverter System
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surpass Evolve Flow Diverter SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Surpass Evolve Flow Diverter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 12 Months (± 3 months) post procedure
Secondary outcomes (1)
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
Measured: 3 Year Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start7 Jul 2020
- Primary completion14 Jul 2025
- Study completion13 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm, IntracranialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Santiago Ortega-Guitierrez, MD, Principal investigator, University of IowaVitor M Pereira, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195568
- Sponsor's protocol ID
- CDM10001444
- Acronym
- EVOLVE
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2019
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System
- ClinicalTrials.gov ID
- NCT04195568
- Acronym / sponsor ID
- EVOLVE / CDM10001444
- Conditions
- Aneurysm, Intracranial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 13 Sep 2028 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surpass Evolve Flow Diverter System | Experimental | Device: Surpass Evolve Flow Diverter SystemThis 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age is ≥ 18 and ≤ 80 years
- Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surpass Evolve Flow Diverter SystemThe 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. | Device | Surpass Evolve Flow Diverter System |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 12 months (± 3 months) post procedure
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.
Primary Safety Endpoint
Time frame: 12 Months (± 3 months) post procedure
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).
1 secondary outcome
Secondary Safety Endpoints
Time frame: 3 Year Follow-Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Ortega-Guitierrez, MD principal investigator
University of Iowa
Vitor M Pereira, MD principal investigator
University Health Network, Toronto
37 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surpass Evolve Flow Diverter System in people with Aneurysm, Intracranial, run by Stryker Neurovascular at 37 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 12 months (± 3 months) post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.