Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)

NCT06872684 | Recruiting DMC FDA Device

• 1 other identifier: CDM10001836
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 10

Brief 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, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.

Conditions

Aneurysm; Aneurysm, Intracranial

Keywords

Saccular Aneurysm; Fusiform Aneurysm; Unruptured Aneurysm; Flow Diverter

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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).

  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).

  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

  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

  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)

  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

Study Arms (1)

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.

Device: Surpass Elite with Guardian Flow Diverter System

Interventions

Surpass Elite with Guardian Flow Diverter System DEVICE

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.

Surpass Elite with Guardian Flow Diverter

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 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.

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 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
• 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

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (10)

Carondelet St. Joseph's Hospital

Tucson, Arizona, 85711, United States

RECRUITING

University of California Davis Health

Davis, California, 95616, United States

RECRUITING

Stanford University School of Medicine

Palo Alto, California, 94304, United States

RECRUITING

Lyerly Neurosurgery, an Affiliate of Baptist

Jacksonville, Florida, 32207, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01803, United States

RECRUITING

Mount Sinai Health System

New York, New York, 10029, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Aneurysm; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Stacy Phung

CONTACT

678-469-2428; stacy.phung@stryker.com

John Strohmeyer

CONTACT

john.strohmeyer@stryker.com

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: February 27, 2025
• First Posted: March 12, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (10)