Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study will be to evaluate a novel, minimally invasive method of treating hydrocephalus in adults. The eShunt® System includes a proprietary eShunt® Delivery System and the eShunt® Implant, a permanent implant that is deployed in a mildly invasive, neuro-interventional procedure. The eShunt® Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.

Detailed Description
-----------------
This is a prospective, multi-center, open label, pilot study of the eShunt® System. The study population consists of patients with post-aneurysmal subarachnoid hemorrhage (SAH) treated for increased intracranial pressure (ICP) resulting in symptomatic hydrocephalus using an external ventricular drain (EVD) to facilitate CSF drainage and who cannot be weaned from the EVD after the hemorrhagic event. After completion of the procedure to place the eShunt® device, the ICP will be monitored and recorded for up to 48 hours. Subjects will then return for follow-up visits that include standard neurological evaluations at 30, 60, 90, 180, and 365 days postimplantation; imaging will also be acquired at 30, 90 and 365 days after implant. Subjects will continue to attend follow-up visits every 180 days thereafter until the study is closed or up to 5 years post-implantation.

Official Title
-----------------
US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus

Conditions
-----------------
Hydrocephalus, Hydrocephalus, Communicating

Intervention / Treatment
-----------------
* Device: eShunt® Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is ≥ 21 years old Patient or legally authorized representative is able and willing to provide written informed consent Post-aneurysmal SAH with Hunt and Hess Grades I-IV with EVD in place for at least 7 days with the need for a permanent CSF shunt determined through a failed EVD clamping trial defined as: Post-clamping ICP of > 20 cmH2O for 15 minutes, or Post-clamping ICP > 25 cmH2O for < 15 minutes with patient intolerance to EVD clamping, or Significant radiographic signs of increasing ventriculomegaly, or Neurological decline attributable to ventriculomegaly and requiring CSF diversion Clinical signs and symptoms of communicating hydrocephalus Neurologically stable without evidence of severe vasospasm Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by subject screening committee (SSC) Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC Exclusion Criteria: Presence of gross blood in CSF Signs or symptoms of obstructive hydrocephalus Active systemic infection or infection detected in CSF Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available Occlusion or stenosis of the internal jugular vein Venous distension in the neck on physical exam Medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arterial venous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency Stroke or transient ischemic attack within 180 days of eShunt Procedure Presence of a deep vein thrombosis superior to the popliteal vein International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds) Presence of a posterior fossa tumor or mass Life expectancy < 1 year Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up Pregnant Unwilling or unable to comply with follow-up requirements

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Arm<br>The Device Arm receives the eShunt® Implant | Device: eShunt® Implant<br>* The eShunt® Implant is intended to drain excess cerebrospinal fluid from the intracranial subarachnoid space to the venous system as a less invasive therapy for treating hydrocephalus.<br>* Other names: eShunt® system;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in ICP | At 24 to 48 hours after eShunt Implant deployment (with EVD remaining clamped) an ICP measurement that indicates: ICP below 20 cmH2O with no periods longer than 15 minutes above 20 cmH2O No episodes of ICP above 25 cmH2O with associated symptoms | 24-48 hours after eShunt Implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Serious Adverse Events | The number of device and/or procedure-related serious adverse events (SAEs) after the implant procedure will be calculated. | 90 days post procedure | 
| Incidence of clinically significant changes in Computed Tomography Imaging (CT/CTA) from baseline. | Clinically significant changes from baseline CT images will be summarized | 1 year post procedure | 
| Number of participants with clinically significant changes in physical and neurologic examination assessments from baseline | Clinically significant changes from baseline physical examination and neurologic examination assessments will be summarized | 1 year post procedure | 
| Summary of Adverse Events | Tabulation of all Adverse Events collected in the study. | 90 days post procedure and at study completion | 
| Changes in Modified Rankin Scale Scores | Changes in Modified Rankin Scale scores from baseline will be summarized. | 1 year post procedure | 
| Number of subjects requiring conversion to conventional CSF shunt | Evaluate the need for CSF diversion by conventional CSF shunt insertion within 12 months after eShunt Implant deployment | 1 year post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eShunt, Endovascular Shunt