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

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.

Study Overview

• Status: Recruiting
• Conditions: Aneurysm; Aneurysm, Intracranial
• Intervention / Treatment: Device: Surpass Elite with Guardian Flow Diverter System

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.

• Study Type: Interventional
• Enrollment (Estimated): 183
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacy Phung; Phone Number: 678-469-2428; Email: stacy.phung@stryker.com
• Study Contact Backup: Name: John Strohmeyer; Email: john.strohmeyer@stryker.com

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Recruiting
      • Carondelet St. Joseph's Hospital
      • Principal Investigator: Alexander Coon, MD
      • Contact: Rachael Taoka; Phone Number: 520-873-1592; Email: Rachael2.taoka@tenethealth.com
  • California
    • Davis, California, United States, 95616
      • Recruiting
      • University of California Davis Health
      • Contact: Savina Nguyen; Phone Number: 916-551-3234; Email: savnguyen@ucdavis.edu
      • Principal Investigator: Ben Waldau, MD, MAS, FAANS, FACS
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University School of Medicine
      • Principal Investigator: Robert Dodd, MD
      • Contact: Banu Priya Rajasekaran; Phone Number: 650-304-6402; Email: bpriya@stanford.edu
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Lyerly Neurosurgery, an Affiliate of Baptist
      • Principal Investigator: Ricardo Hanel, MD
      • Contact: Karen Yesensky; Phone Number: 904-202-7091; Email: Karen.Yesensky@bmcjax.com
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Principal Investigator: Koji Ebersole, MD
      • Contact: Max Hardenbrook; Phone Number: 913-588-6191; Email: mhardenbrook@kumc.edu
  • Massachusetts
    • Burlington, Massachusetts, United States, 01803
      • Recruiting
      • Lahey Hospital and Medical Center
      • Contact: Sandy Alvarez; Phone Number: 786-580-0186; Email: Sandy.L.Alvarez@lahey.org
      • Principal Investigator: Emanuele Orru', MD
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Health System
      • Contact: Emily Svendsen; Phone Number: 212-241-3238; Email: emily.svendsen@mountsinai.org
      • Principal Investigator: Reade DeLeacy, MD
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Principal Investigator: David Fiorella, MD
      • Contact: Marlene Baumeister; Phone Number: 631-444-1610; Email: marlene.baumeister@stonybrookmedicine.edu
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Principal Investigator: Mark Bain, MD
      • Contact: Barmen Joyce; Phone Number: 216 445-5869; Email: BARMENJ2@ccf.org
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Principal Investigator: Ryan Priest, MD
      • Contact: Emilie Nagle; Phone Number: 503-418-1722; Email: bode@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age is ≥18 and ≤80 years at the time of consent

2. Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:

   1. Is located on the internal carotid artery or its branches
   2. 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
   3. Aneurysm is either saccular or fusiform in nature
3. Has a parent vessel diameter ≥ 3.0 mm to ≤ 6.0 mm at the largest diameter
4. 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.

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 trial)
4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
5. 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
6. Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
7. 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
8. Has a known severe allergy to nickel, chromium cobalt, tungsten, or platinum
9. Patients with heparin hypersensitivity, including patients with a previous incident of Heparin-Induced Thrombocytopenia (HIT).
10. Modified Rankin Score (mRS) assessment is ≥ 3 at pre-procedure exam
11. Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days prior to the index procedure)
12. Subarachnoid hemorrhage occurred within 30 days prior to the index procedure
13. 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
14. Has more than one intracranial aneurysm (IA) that requires treatment within 12 months after the index procedure
15. Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 84 days prior to treatment date
16. Chronic anticoagulation therapy is ongoing or known coagulopathy exists
17. Has atrial fibrillation with or without pacemaker.
18. 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
19. Has acute life-threatening illness (e.g., acute kidney or heart failure) other than the neurological disease to be treated in this trial
20. Evidence of active infection at the time of treatment
21. Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
22. 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
23. Pregnant or breast- feeding women or women who wish to become pregnant during the length of trial participation
24. Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
25. Enrollment in another study 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 Elite with Guardian Flow Diverter; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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)	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	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	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

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Alexander Coon, MD, Carondelet at St. Joesphs; Principal Investigator: David Fiorella, MD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2031

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Flow Diverter; Saccular Aneurysm; Fusiform Aneurysm; Unruptured Aneurysm
• 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: CDM10001836

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes