Brief Title
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)
Official Title
Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt™ System in the Treatment of Communicating Hydrocephalus
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 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.
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 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.
Study Type
Interventional
Primary Outcome
Reduction in intracranial pressure (ICP)
Secondary Outcome
Number of subjects requiring conversion to conventional CSF shunt
Condition
Hydrocephalus, Communicating
Intervention
eShunt™ Implant
Study Arms / Comparison Groups
Treatment Arm
Description: The Treatment Arm receives the eShunt implant
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
October 1, 2020
Completion Date
January 1, 2023
Primary Completion Date
December 1, 2022
Eligibility Criteria
Inclusion Criteria:
1. Age > 18
2. Subject provides Informed Consent (IC)
3. 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:
1. Post-clamping ICP of > 20 cmH2O for 15 min, or
2. Post-clamping ICP > 25 cmH2O for < 15 min with patient intolerance to EVD
clamping
3. Post-clamping ICP >15 cmH2O for 15 min with radiographic evidence of
ventriculomegaly
4. Clinical signs and symptoms of communicating hydrocephalus
5. Neurologically stable without evidence of severe vasospasm
6. 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)
7. 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:
1. Patient is in a state of unconsciousness or is unable to understand the information
provided in the Informed Consent Form for this study
2. Indication of obstructive hydrocephalus
3. Presence of gross blood in CSF from EVD
4. Pregnant
5. Unwilling or unable to comply with follow up requirements
6. Active systemic infection or infection detected in CSF
7. Life expectancy < 1 year
8. Hypersensitivity or contraindication to heparin or radiographic contrast agents which
cannot be adequately pre-medicated, desensitized or where no alternative is available
9. Occlusion or stenosis of the internal jugular vein
10. Venous distension in the neck on physical exam
11. Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram
12. History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases
of emergency
13. Clearly antecedent stroke unrelated to post-aneurysmal SAH
14. Patient is currently participating in another investigational drug or device trial
that could conflict with study data collection or follow-up
15. 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
16. Presence of a deep vein thrombosis superior to the popliteal segment of the femoral
vein
17. International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results
outside of normal range (INR 0.8-1.4; PTT 25-35 secs.)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pedro M Lylyk, MD, 5129947597, [email protected]
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT04758611
Organization ID
CLIN-0001
Responsible Party
Sponsor
Study Sponsor
CereVasc Inc
Collaborators
AlvaMed, Inc.
Study Sponsor
Pedro M Lylyk, MD, Principal Investigator, Clinica Sagrada Familia
Verification Date
August 2022