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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hydrocephalus; Hydrocephalus, Communicating
• Intervention / Treatment: Device: eShunt® Implant

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DJ Cass; Email: djcass@cerevasc.com
• Study Contact Backup: Name: Ona Whelove; Phone Number: 4155152885; Email: clinicaltrials@cerevasc.com

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center Department of Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

  1. Post-clamping ICP of > 20 cmH2O for 15 minutes, or
  2. Post-clamping ICP > 25 cmH2O for < 15 minutes with patient intolerance to EVD clamping, or
  3. Significant radiographic signs of increasing ventriculomegaly, or
  4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Arm; The Device Arm receives the eShunt® Implant	Device: eShunt® Implant; 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.; Other Names: eShunt®; 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

Collaborators and Investigators

• Sponsor: CereVasc Inc
• Collaborators: AlvaMed, Inc.; Simplified Clinical Data Systems, LLC; Bioscience Consulting, Inc.

Publications and helpful links

General Publications

• Heilman CB, Basil GW, Beneduce BM, Malek AM. Anatomical characterization of the inferior petrosal sinus and adjacent cerebellopontine angle cistern for development of an endovascular transdural cerebrospinal fluid shunt. J Neurointerv Surg. 2019 Jun;11(6):598-602. doi: 10.1136/neurintsurg-2018-014445. Epub 2019 Jan 9.
• Lylyk P, Lylyk I, Bleise C, Scrivano E, Lylyk PN, Beneduce B, Heilman CB, Malek AM. First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt. J Neurointerv Surg. 2022 May;14(5):495-9. doi: 10.1136/neurintsurg-2021-018136. Epub 2021 Dec 3.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: eShunt; Endovascular Shunt
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: CLIN-0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes