The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Sh… (NCT04758611) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)
Argentina20 participantsStarted 2020-10-01
Plain-language summary
The eShuntâ„¢ 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✓. 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
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
What they're measuring
1
Reduction in intracranial pressure (ICP)
Timeframe: 36-48 hours following eShunt Implant deployment
✕. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available