Last updated 29 days ago
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus with an Endovascular Shunt)
30 patients around the world
Available in Argentina
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.
CereVasc Inc
1Research sites
30Patients around the world
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Age > 18Subject 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, orPost-clamping ICP > 25 cmH2O for < 15 min with patient intolerance to EVD clampingPost-clamping ICP >15 cmH2O for 15 min with radiographic evidence of ventriculomegalyClinical signs and symptoms of communicating hydrocephalusNeurologically stable without evidence of severe vasospasmPre-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
- Patient is in a state of unconsciousness or is unable to understand the information provided in the Informed Consent Form for this studyIndication of obstructive hydrocephalusPresence of gross blood in CSF from EVDPregnantUnwilling or unable to comply with follow up requirementsActive systemic infection or infection detected in CSFLife expectancy < 1 yearHypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is availableOcclusion or stenosis of the internal jugular veinVenous distension in the neck on physical examAtrial septal defect or patent foramen ovale identified on cardiac echocardiogramHistory of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergencyClearly antecedent stroke unrelated to post-aneurysmal SAHPatient is currently participating in another investigational drug or device trial that could conflict with study data collection or follow-upOther medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation as determined by the study InvestigatorPresence of a deep vein thrombosis superior to the popliteal segment of the femoral veinInternational Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 secs.)
Sites
Clínica La Sagrada Familia
Recruiting
StudyETCHES I
SponsorCereVasc Inc
Study typeInterventional
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04758611
