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

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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