Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
CereVasc Inc
Summary
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
Description
The STRIDE study is a prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Each subject must meet the following criteria: 1. Patients ≥60 years old on the day of study informed consent 2. Patient or legally authorized representative is able and willing to provide written informed consent 3. History or evidence of gait impairment with a duration ≥3 months 4. Clinical presentation consistent with NPH including two or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with all of the following: 1. Brain MRI signs of ventricular enlargement disproportion…
Interventions
- DeviceCereVasc eShunt System
The eShunt System consists of the following components: * eShunt Implant * eShunt Delivery Catheter and Transfer Tool * eShunt Anchor
- DeviceVP Shunt
Control arm - VP shunt
Locations (31)
- University of Southern CaliforniaLos Angeles, California
- Yale UniversityNew Haven, Connecticut
- Baptist Medical Center - JacksonvilleJacksonville, Florida
- University of South FloridaTampa, Florida
- Northwestern UniversityChicago, Illinois
- Advocate Lutheran General HospitalPark Ridge, Illinois