Actively Recruiting
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
Led by Stryker Neurovascular · Updated on 2026-04-08
183
Participants Needed
10
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is 18 to 80 years at the time of consent
- Has a single unruptured intracranial aneurysm located on the internal carotid artery or its branches
- Aneurysm has a wide neck (neck width 4 mm or more, or dome to neck ratio 2.0 or less) or no discernible neck
- Aneurysm is saccular or fusiform in shape
- Parent vessel diameter is between 3.0 mm and 6.0 mm
- The risk-benefit of endovascular treatment outweighs the risk of aneurysm rupture during expected lifetime if untreated
You will not qualify if you...
- Has an extradural target aneurysm
- Has a target aneurysm in the posterior circulation
- Perforator or branch vessel arises from the aneurysm body or neck (except if branches arise separately from parent vessel)
- Has a true bifurcation aneurysm at a vessel branching point
- Vessel characteristics prevent safe access or proper device deployment (severe tortuosity, stenosis over 70%, or unsuitable morphology)
- Previous treatment for the target aneurysm or parent artery that interferes with device placement
- Contraindications to antiplatelet medications, anesthesia, or allergy to contrast dye
- Severe allergy to nickel, chromium cobalt, tungsten, or platinum
- History of heparin hypersensitivity or Heparin-Induced Thrombocytopenia (HIT)
- Modified Rankin Score 3 or higher before procedure
- Unstable neurologic deficit worsening in last 30 days
- Subarachnoid hemorrhage within 30 days before procedure
- Major surgery within 30 days before or planned within 120 days after procedure
- More than one intracranial aneurysm requiring treatment within 12 months
- Intracranial implant in symptomatic or vascular area within 84 days before treatment
- Ongoing chronic anticoagulation therapy or known coagulopathy
- Atrial fibrillation with or without pacemaker
- Serious concurrent medical conditions including recent heart attack, heart failure, carotid stenosis, kidney failure, lung disease, uncontrolled diabetes, progressive neurologic disorders, terminal cancer, vasculitis, or high stroke risk
- Acute life-threatening illness other than neurologic disease treated in trial
- Active infection at treatment time
- Life expectancy less than 5 years due to other illness
- Unable to comply with follow-up due to dementia, psychiatric problems, substance abuse, or history of non-compliance
- Pregnant, breastfeeding, or planning pregnancy during trial
- Presence of intracranial mass (tumor except meningioma), abscess, infection, or untreated arteriovenous malformation in aneurysm area
- Enrollment in another study with investigational product that may affect results
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Carondelet St. Joseph's Hospital
Tucson, Arizona, United States, 85711
Actively Recruiting
2
University of California Davis Health
Davis, California, United States, 95616
Actively Recruiting
3
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Actively Recruiting
4
Lyerly Neurosurgery, an Affiliate of Baptist
Jacksonville, Florida, United States, 32207
Actively Recruiting
5
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
6
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01803
Actively Recruiting
7
Mount Sinai Health System
New York, New York, United States, 10029
Actively Recruiting
8
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
S
Stacy Phung
CONTACT
J
John Strohmeyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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