Status:
RECRUITING
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)
Lead Sponsor:
CereVasc Inc
Collaborating Sponsors:
AlvaMed, Inc.
Bioscience Consulting, Inc.
Conditions:
Hydrocephalus, Communicating
Hydrocephalus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 d...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- Post-clamping ICP \>15 cmH2O for 15 min with radiographic evidence of ventriculomegaly
- Clinical signs and symptoms of communicating hydrocephalus
- 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
- 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
- Presence of a deep vein thrombosis superior to the popliteal segment of the femoral vein
- International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 secs.)
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04758611
Start Date
October 1 2020
End Date
December 1 2027
Last Update
June 19 2025
Active Locations (1)
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1
Clínica La Sagrada Familia
Buenos Aires, Ciudad A. de Buenos Aires, Argentina, C1426B