Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter
Stryker Neurovascular
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.
Description
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 millimeters (mm) and ≤ 6.0 mm and located on the ICA or its branches.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age is ≥18 and ≤80 years at the time of consent 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 wide neck (wide neck typically defined as neck width ≥ 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 mm to ≤ 6.0 mm at the largest diameter 4. There is documented risk-benefit of endovascular treatment that outweighs the ri…
Interventions
- DeviceSurpass 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 HospitalTucson, Arizona
- University of California Davis HealthDavis, California
- Stanford University School of MedicinePalo Alto, California
- Lyerly Neurosurgery, an Affiliate of BaptistJacksonville, Florida
- University of Kansas Medical CenterKansas City, Kansas
- Lahey Hospital and Medical CenterBurlington, Massachusetts