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RECRUITING
NCT06872684
NA

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

Sponsor: Stryker Neurovascular

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

183

Start Date

2025-06-20

Completion Date

2031-01-31

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

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.

Locations (10)

Carondelet St. Joseph's Hospital

Tucson, Arizona, United States

University of California Davis Health

Davis, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

Lyerly Neurosurgery, an Affiliate of Baptist

Jacksonville, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Mount Sinai Health System

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States