AneurysmGUARDNCT06872684
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
A study testing Surpass Elite with Guardian Flow Diverter System in people with Aneurysm and Aneurysm, Intracranial, run by Stryker Neurovascular at 20 sites in United States.
Trial summary
The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysm, Aneurysm, Intracranial
- What is being tested?
- Surpass Elite with Guardian Flow Diverter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 20 sitesUnited States
- Study dates
- 20 Jun 2025to 31 Jan 2031
- Phase
- Interventional
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 at the time of consent
- Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:
- Is located on the internal carotid artery or its branches
- Has a wide neck (wide neck typically defined as neck width ≥ 4 millimeter (mm), or dome to neck ratio ≤ 2.0) or no discernible neck
- Aneurysm is either saccular or fusiform in nature
- Has a parent vessel diameter ≥ 3.0 mm to ≤ 6.0 mm at the largest diameter
- There is documented risk-benefit 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 trial)
- Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
- Has vessel characteristics, such as severe tortuosity (cavernous Internal Carotid Artery (cICA) Type IV1), stenosis (>70%), or morphology that would preclude safe endovascular access or proper deployment of the trial device to the target aneurysm
- Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
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- Has a medical contraindication to trial 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
- Patients with heparin hypersensitivity, including patients with a previous incident of Heparin-Induced Thrombocytopenia (HIT).
- Modified Rankin Score (mRS) assessment is ≥ 3 at pre-procedure exam
- Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days prior to the index procedure)
- Subarachnoid hemorrhage occurred within 30 days prior to the index procedure
- Major surgery (including previous intracranial implant) either occurred within 30 days prior to the index procedure date or is planned to occur within 120 days following the index procedure date
- Has more than one intracranial aneurysm (IA) that requires treatment within 12 months after the index procedure
- Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 84 days prior to treatment date
- Chronic anticoagulation therapy is ongoing or known coagulopathy exists
- Has atrial fibrillation with or without pacemaker.
- Has other known serious concurrent medical conditions such as cardiovascular disease (including recent myocardial infarction [<12 weeks], symptomatic congestive heart failure, or carotid stenosis), kidney failure (>2.0 mg/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 (e.g., acute kidney or heart failure) other than the neurological disease to be treated in this trial
- Evidence of active infection at the time of treatment
- Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
- Unable to comply with the trial follow up requirements due to conditions such as dementia or psychiatric problems, active substance abuse, or history of non-compliance with medical advice, as determined by the investigator
- Pregnant or breast- feeding women or women who wish to become pregnant during the length of trial participation
- Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
- Enrollment in another study involving an investigational product that could confound the outcomes of this trial
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
John Strohmeyer contact
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01803
Sandy Alvarez, 786-580-0186, Sandy.L.Alvarez@lahey.org
Emanuele Orru', MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Barmen Joyce, 216 445-5869, BARMENJ2@ccf.org
Mark Bain, MD
- Recruiting
University of California Davis Health
Davis, California, 95616
Savina Nguyen, 916-551-3234, savnguyen@ucdavis.edu
Ben Waldau, MD, MAS, FAANS, FACS
- Recruiting
The University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Elizabeth Hennessey, 409-772-2138, eahennes@utmb.edu
Christopher Young, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Lauren Snyder, 317-968-8172, lmillar@iu.edu
Bradley Bohndstedt, MD
- Recruiting
University of Iowa Healthcare
Iowa City, Iowa, 52242
Heena Olalde, 319-356-8326, heena-olalde@uiowa.edu
Santiago Ortega, MD
- Recruiting
Lyerly Neurosurgery, an Affiliate of Baptist
Jacksonville, Florida, 32207
Karen Yesensky, 904-202-7091, karen.yesensky@bmcjax.com
Ricardo Hanel, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Max Hardenbrook, 913-588-6191, mhardenbrook@kumc.edu
Koji Ebersole, MD
- Recruiting
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
Victoria Rueda, 310-562-9694, vrueda@mednet.ucla.edu
Gary Duckwiler, MD
- Recruiting
Semmes Murphey
Memphis, Tennessee, 38120
Wendell Barnett, 901-260-6124, wbarnett@semmes-murphey.com
Daniel Hoit, MD
- Recruiting
Baptist Hospital of Miami
Miami, Florida, 33176
Marianela Cruz, 786-596-5175, marianela.cruz@baptisthealth.net
Italo Linfante, MD
- Recruiting
Robert Wood Johnson University Medical Center
New Brunswick, New Jersey, 08901
Christine Yohn, 908-328-4210, cy253@rwjms.rutgers.edu
Gaurav Gupta, MD
- Recruiting
Mount Sinai Health System
New York, New York, 10029
Emily Svendsen, 212-241-3238, emily.svendsen@mountsinai.org
Reade DeLeacy, MD
- Recruiting
Stanford University School of Medicine
Palo Alto, California, 94304
Banu Priya Rajasekaran, 650-304-6402, bpriya@stanford.edu
Robert Dodd, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Leah Coghlan, 215-341-5864, Leah.coghlan@pennmedicine.upenn.edu
Visish Srinivasan, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Emilie Nagle, 503-418-1722, bode@ohsu.edu
Ryan Priest, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14618
Tilor Hallquist, 585-261-8969, tilor_hallquist@urmc.rochester.edu
Matthew Bender, MD
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Marlene Baumeister, 631-444-1610, marlene.baumeister@stonybrookmedicine.edu
David Fiorella, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Lyanna Gomez, 718-920-2512, lygomez@montefiore.org
David Altschul, MD
- Recruiting
Carondelet St. Joseph's Hospital
Tucson, Arizona, 85711
Rachael Taoka, 520-873-1592, Rachael2.taoka@tenethealth.com
Alexander Coon, MD
About this study
Official title: Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter
The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.
Read the detailed description
The Surpass Elite with Guardian Flow Diverter System is indicated for use in the endovascular treatment of adults (age 18 or above) with unruptured wide-neck saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 3.0 millimeters (mm) and ≤ 6.0 mm and located on the ICA or its branches.
- Conditions
- Aneurysm, Aneurysm, Intracranial
- Being tested
- Surpass Elite with Guardian Flow Diverter System
- Keywords
- Saccular Aneurysm, Fusiform Aneurysm, Unruptured Aneurysm, Flow Diverter
- Medical subject headings
- Aneurysm, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surpass Elite with Guardian Flow Diverter SystemDevice
The Surpass Elite with Guardian Flow Diverter System is indicated for use in the endovascular treatment of adults (age 18 or above) with unruptured wide-neck saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 3.0 millimeter (mm) and ≤ 6.0 mm and located on the Internal Carotid Artery (ICA) or its branches.
| Study group | Role | What they receive |
|---|---|---|
| Surpass Elite with Guardian Flow Diverter | Experimental | This is a prospective single arm study in which all subjects who present for Surpass Elite with Guardian flow diverter implantation, provide informed consent, and meet inclusion/exclusion criteria may receive treatment. Receives: Device: Surpass Elite with Guardian Flow Diverter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint: Number of subjects with neurologic death or major ipsilateral stroke through 12 months as adjudicated by an independent Clinical Events Committee (CEC).
Neurological death defined as stroke-related death and related to the vascular territory associated with target aneurysm treatment. Major ipsilateral stroke defined as a stroke with an increase in National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 points persisting ≥ 24 hours and related to the vascular territory associated with target aneurysm treatment.
Measured: 12 month ± 3 months
The primary efficacy endpoint: Number of subjects with 100% occlusion of the target aneurysm without significant parent artery stenosis, and with no target aneurysm retreatment through the 12-month follow-up visit timepoint.
The primary efficacy endpoint is a composite of 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (significant parent artery stenosis is defined as > 50% stenosis, per independent core lab assessment of digital subtraction angiography [DSA] images acquired at 12 months [± 90 days] post-procedure), and with no target aneurysm retreatment through the 12-month follow-up visit timepoint.
Measured: 12 month ± 3 months
Secondary outcomes (7)
Secondary Safety Endpoint #1: Number of subjects with neurological death or disabling stroke as adjudicated by an independent Clinical Events Committee (CEC).
Neurological death defined as stroke-related death and related to the vascular territory associated with target aneurysm treatment. Disabling stroke defined as stroke related to the vascular territory associated with target aneurysm treatment that results in a modified Rankin Score (mRS) score ≥ 3, as assessed by an independent qualified (certified or with documented qualification per institution standard of care) assessor at a minimum of 90 days post stroke event.
The number of subjects with neurological deaths or disabling strokes as adjudicated by an independent Clinical Events Committee (CEC) will be analyzed.
Measured: 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System
Secondary Safety Endpoint #2: Number of subjects with stroke related to the vascular territory associated with target aneurysm treatment as adjudicated by an independent Clinical Events Committee (CEC).
The number of subjects with strokes related to the vascular territory associated with target aneurysm treatment as adjudicated by an independent Clinical Events Committee (CEC) will be analyzed.
Measured: 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System
Secondary Safety Endpoint #3: Number of subjects with combined stroke and transient ischemic attack (TIA) events as adjudicated by a CEC
The number of subjects with combined stroke and transient ischemic attack (TIA) events as adjudicated by an independent Clinical Events Committee (CEC) will be analyzed
Measured: 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System
Secondary Efficacy Endpoint #1: Number of subjects with 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm at follow-up visits
The number of subjects with 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm at follow-up visits, per independent core lab assessment of DSA images will be analyzed
Measured: 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System
Secondary Efficacy Endpoint #2: Number of subjects with 100% occlusion of the target aneurysm at follow-up visits, per independent core lab assessment of any images (including but not limited to MRA and CTA)
100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm at follow-up visits, per independent core lab assessment of any images (including but not limited to MRA and CTA)
Measured: 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System
Secondary Efficacy Endpoint #3: Number of subjects with significant (> 50% stenosis) parent artery stenosis as determined by independent core lab post-procedure
The number of subjects with significant (> 50% stenosis) parent artery stenosis as determined by independent core lab post-procedure will be analyzed
Measured: 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System
Secondary Efficacy Endpoint #4: Number of subjects with target aneurysm retreatment.
The number of subjects with target aneurysm retreatment will be analyzed
Measured: 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start20 Jun 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies 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
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872684
- Sponsor's protocol ID
- CDM10001836
- Acronym
- GUARD
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes