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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Carondelet St. Joseph's Hospital
RECRUITING
Tucson
California
University of California Davis Health
RECRUITING
Davis
Stanford University School of Medicine
RECRUITING
Palo Alto
Florida
Lyerly Neurosurgery, an Affiliate of Baptist
RECRUITING
Jacksonville
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Lahey Hospital and Medical Center
RECRUITING
Burlington
New York
Mount Sinai Health System
RECRUITING
New York
Stony Brook University Hospital
RECRUITING
Stony Brook
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oregon
Oregon Health & Science University
RECRUITING
Portland
Contact Information
Primary
Stacy Phung
stacy.phung@stryker.com
678-469-2428
Backup
John Strohmeyer
john.strohmeyer@stryker.com
Time Frame
Start Date: 2025-06-20
Estimated Completion Date: 2031-01-31
Participants
Target number of participants: 183
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Stryker Neurovascular

This content was sourced from clinicaltrials.gov