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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Stryker Neurovascular
Study ID
NCT06872684
Status
Recruiting
Apply to this trial

Conditions

  • Aneurysm
  • Aneurysm, Intracranial

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 20, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
183 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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). [ Time Frame: 12 month ± 3 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Carondelet St. Joseph's HospitalTucsonArizona85711
Rachael Taoka
[email protected]
520-873-1592
Alexander Coon, MD (PRINCIPAL_INVESTIGATOR)
University of California Davis HealthDavisCalifornia95616
Savina Nguyen
[email protected]
916-551-3234
Ben Waldau, MD, MAS, FAANS, FACS (PRINCIPAL_INVESTIGATOR)
Stanford University School of MedicinePalo AltoCalifornia94304
Banu Priya Rajasekaran
[email protected]
650-304-6402
Robert Dodd, MD (PRINCIPAL_INVESTIGATOR)
Lyerly Neurosurgery, an Affiliate of BaptistJacksonvilleFlorida32207
Karen Yesensky
[email protected]
904-202-7091
Ricardo Hanel, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Max Hardenbrook
[email protected]
913-588-6191
Koji Ebersole, MD (PRINCIPAL_INVESTIGATOR)
Lahey Hospital and Medical CenterBurlingtonMassachusetts01803
Sandy Alvarez
[email protected]
786-580-0186
Emanuele Orru', MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai Health SystemNew YorkNew York10029
Emily Svendsen
[email protected]
212-241-3238
Reade DeLeacy, MD (PRINCIPAL_INVESTIGATOR)
Stony Brook University HospitalStony BrookNew York11794
Marlene Baumeister
[email protected]
631-444-1610
David Fiorella, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Barmen Joyce
[email protected]
216 445-5869
Mark Bain, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Emilie Nagle
[email protected]
503-418-1722
Ryan Priest, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By research site
Carondelet St. Joseph's Hospital· Tucson, AZUniversity of California Davis Health· Davis, CAStanford University School of Medicine· Palo Alto, CALyerly Neurosurgery, an Affiliate of Baptist· Jacksonville, FLUniversity of Kansas Medical Center· Kansas City, KSLahey Hospital and Medical Center· Burlington, MA

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