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Search / Trial NCT06872684

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

Launched by STRYKER NEUROVASCULAR · Mar 10, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Saccular Aneurysm Fusiform Aneurysm Unruptured Aneurysm Flow Diverter

ClinConnect Summary

This clinical trial is studying a new medical device called the Surpass Elite with Guardian Flow Diverter System, which is designed to treat certain types of unruptured brain aneurysms. A brain aneurysm is a weak spot in a blood vessel in the brain that can bulge and potentially cause serious problems if it bursts. This trial focuses on aneurysms located in a major artery in the brain called the internal carotid artery or its branches, especially those with wide openings or specific shapes that can be challenging to treat.

People who may be eligible for this trial are adults aged 18 to 80 who have a single unruptured brain aneurysm that fits these specific size and location criteria. To take part, the aneurysm should be located on the internal carotid artery or its branches and meet certain size requirements. Participants should not have had previous treatments for the aneurysm, and they should be generally healthy enough for the procedure and follow-up care. If accepted, participants will receive treatment using the study device, which is inserted through blood vessels to help protect the aneurysm and reduce the risk of rupture. The trial will carefully monitor safety and how well the device works, with regular check-ins after the procedure to ensure participants’ health and recovery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age is ≥18 to ≤80 years
  • 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 neck ≥ 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 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 to the target aneurysm necessary for treatment with the trial device
  • 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
  • 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 heart 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 dementia or psychiatric problem, substance abuse, or history of non-compliance with medical advice
  • 23. Pregnancy at time of enrollment
  • 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

About Stryker Neurovascular

Stryker Neurovascular is a leading medical technology company focused on developing innovative solutions for the treatment of neurovascular conditions. As a subsidiary of Stryker Corporation, it specializes in advanced products and therapies aimed at improving patient outcomes in the fields of stroke intervention and surgical treatment of neurovascular diseases. With a commitment to research and development, Stryker Neurovascular works collaboratively with healthcare professionals to deliver cutting-edge technologies that enhance procedural efficiency and safety, ultimately striving to transform the standard of care in neurovascular medicine.

Locations

Burlington, Massachusetts, United States

Tucson, Arizona, United States

Patients applied

0 patients applied

Trial Officials

Alexander Coon, MD

Principal Investigator

Carondelet at St. Joesphs

David Fiorella, MD

Principal Investigator

Stony Brook University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported