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

Primary Purpose

Hydrocephalus, Hydrocephalus, Communicating

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eShunt® Implant
Sponsored by
CereVasc Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrocephalus focused on measuring eShunt, Endovascular Shunt

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale UniversityRecruiting
  • Montefiore Medical Center Department of NeurosurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device Arm

Arm Description

The Device Arm receives the eShunt® Implant

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Occurrence of Serious Adverse Events
The number of device and/or procedure-related serious adverse events (SAEs) after the implant procedure will be calculated.
Incidence of clinically significant changes in Computed Tomography Imaging (CT/CTA) from baseline.
Clinically significant changes from baseline CT images will be summarized
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
Summary of Adverse Events
Tabulation of all Adverse Events collected in the study.
Changes in Modified Rankin Scale Scores
Changes in Modified Rankin Scale scores from baseline will be summarized.
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

Full Information

First Posted
August 12, 2022
Last Updated
July 7, 2023
Sponsor
CereVasc Inc
Collaborators
AlvaMed, Inc., Bioscience Consulting, Inc., Simplified Clinical Data Systems, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05501002
Brief Title
Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus
Official Title
US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
August 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CereVasc Inc
Collaborators
AlvaMed, Inc., Bioscience Consulting, Inc., Simplified Clinical Data Systems, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Hydrocephalus, Communicating
Keywords
eShunt, Endovascular Shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device Arm
Arm Type
Experimental
Arm Description
The Device Arm receives the eShunt® Implant
Intervention Type
Device
Intervention Name(s)
eShunt® Implant
Other Intervention Name(s)
eShunt®, eShunt® system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in ICP
Description
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
Time Frame
24-48 hours after eShunt Implant placement
Secondary Outcome Measure Information:
Title
Occurrence of Serious Adverse Events
Description
The number of device and/or procedure-related serious adverse events (SAEs) after the implant procedure will be calculated.
Time Frame
90 days post procedure
Title
Incidence of clinically significant changes in Computed Tomography Imaging (CT/CTA) from baseline.
Description
Clinically significant changes from baseline CT images will be summarized
Time Frame
1 year post procedure
Title
Number of participants with clinically significant changes in physical and neurologic examination assessments from baseline
Description
Clinically significant changes from baseline physical examination and neurologic examination assessments will be summarized
Time Frame
1 year post procedure
Title
Summary of Adverse Events
Description
Tabulation of all Adverse Events collected in the study.
Time Frame
90 days post procedure and at study completion
Title
Changes in Modified Rankin Scale Scores
Description
Changes in Modified Rankin Scale scores from baseline will be summarized.
Time Frame
1 year post procedure
Title
Number of subjects requiring conversion to conventional CSF shunt
Description
Evaluate the need for CSF diversion by conventional CSF shunt insertion within 12 months after eShunt Implant deployment
Time Frame
1 year post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ona Whelove
Phone
4155152885
Email
clinicaltrials@cerevasc.com
First Name & Middle Initial & Last Name or Official Title & Degree
DJ Cass
Email
djcass@cerevasc.com
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Fraczkiewicz
Phone
203-785-3490
First Name & Middle Initial & Last Name & Degree
Liz Brown
Email
elizabeth.brown@yale.edu
First Name & Middle Initial & Last Name & Degree
Charles Matouk, MD
Facility Name
Montefiore Medical Center Department of Neurosurgery
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genesis Liriano
Phone
718-920-2469
Email
gliriano@montefiore.org
First Name & Middle Initial & Last Name & Degree
David Altschul, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34862267
Citation
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.
Results Reference
background
PubMed Identifier
30626626
Citation
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.
Results Reference
background

Learn more about this trial

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

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