The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) (ETCHES I)

  • STATUS
    Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    30
  • sponsor
    CereVasc Inc
Updated on 13 April 2022

Summary

The eShunt™ System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally 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, single-center, open label, single-arm 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 following the hemorrhagic event.

The study will be performed a single site with up to 30 subjects who meet the inclusion and exclusion criteria for the study. Subjects will be evaluated every 30 days for the first 90 days following eShunt Implant deployment with standard neurological evaluation appropriate for patients with communicating hydrocephalus. In addition, follow-up will occur at 180 days, 12 and 24 months post-operatively and will include imaging in addition to the standard neurological evaluation.

Details
Condition Hydrocephalus, Communicating, Hydrocephalus
Treatment eShunt™ Implant
Clinical Study IdentifierNCT04758611
SponsorCereVasc Inc
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age > 18
Subject provides Informed Consent (IC)
Post-aneurysmal SAH with Hunt and Hess Grades I-IV with EVD in place 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 min, or
Post-clamping ICP > 25 cmH2O for < 15 min with patient intolerance to EVD clamping
Clinical signs and symptoms of communicating hydrocephalus
Post-clamping ICP >15 cmH2O for 15 min with radiographic evidence of ventriculomegaly
Neurologically stable without evidence of severe vasospasm
Pre-procedure MRI with gadolinium confirmation of IPS (inferior petrosal sinus) and CPA (cerebellopontine angle) cistern anatomy suitable for eShunt Implant deployment as confirmed by SSC (subject screening committee)
Pre-procedure CT confirmation of no obstruction preventing CPA cistern access at target implant site (e.g., petrous bone) as confirmed by SSC

Exclusion Criteria

Patient is in a state of unconsciousness or is unable to understand the information provided in the Informed Consent Form for this study
Indication of obstructive hydrocephalus
Presence of gross blood in CSF from EVD
Pregnant
Unwilling or unable to comply with follow up requirements
Active systemic infection or infection detected in CSF
Life expectancy < 1 year
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
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
Clearly antecedent stroke unrelated to post-aneurysmal SAH
Patient is currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation as determined by the study Investigator
International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 secs.)
Presence of a deep vein thrombosis superior to the popliteal segment of the femoral vein
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