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

  • STATUS
    Recruiting
  • End date
    Aug 19, 2028
  • participants needed
    10
  • sponsor
    CereVasc Inc
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Updated on 19 October 2022
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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.

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.

Details
Condition Hydrocephalus, Hydrocephalus, Communicating
Treatment eShunt® Implant
Clinical Study IdentifierNCT05501002
SponsorCereVasc Inc
Last Modified on19 October 2022

Eligibility

 Yes No Not Sure

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](telnet://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](telnet://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
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