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

Primary Purpose

Hydrocephalus, Communicating, Hydrocephalus

Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
eShunt™ Implant
Sponsored by
CereVasc Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrocephalus, Communicating focused on measuring eShunt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Clínica La Sagrada FamiliaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

The Treatment Arm receives the eShunt implant

Outcomes

Primary Outcome Measures

Reduction in intracranial pressure (ICP)
At 36-48 hours following eShunt Implant deployment and with EVD remaining clamped, an ICP assessment that demonstrates: 1) ICP below 20 cmH2O as measured by the EVD with no periods longer than 15 minutes above 20 cmH2O; and 2) No episodes of ICP, measured by EVD, above 25 cmH2O with associated subject symptoms

Secondary Outcome Measures

Number of subjects requiring conversion to conventional CSF shunt
Evaluate the need for CSF diversion by conventional CSF shunt insertion within the 24 months following eShunt Implant deployment
Incidence of clinically significant abnormal laboratory test results
Clinically significant changes from baseline laboratory test results will be summarized
Incidence of clinically significant changes from baseline MRI imaging
Clinically significant changes from baseline MRI images will be summarized
Incidence of clinically significant changes from baseline CT imaging
Clinically significant changes from baseline CT images will be summarized

Full Information

First Posted
February 9, 2021
Last Updated
July 7, 2023
Sponsor
CereVasc Inc
Collaborators
AlvaMed, Inc., Bioscience Consulting, Inc., Simplified Clinical Data Systems, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04758611
Brief Title
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)
Acronym
ETCHES I
Official Title
Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt™ System in the Treatment of Communicating Hydrocephalus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CereVasc Inc
Collaborators
AlvaMed, Inc., Bioscience Consulting, Inc., Simplified Clinical Data Systems, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Communicating, Hydrocephalus
Keywords
eShunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single-center, open-label, single-arm pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
The Treatment Arm receives the eShunt implant
Intervention Type
Device
Intervention Name(s)
eShunt™ Implant
Other Intervention Name(s)
eShunt™, eShunt™ System
Intervention Description
The eShunt™ Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system as a minimally invasive treatment for communicating hydrocephalus.
Primary Outcome Measure Information:
Title
Reduction in intracranial pressure (ICP)
Description
At 36-48 hours following eShunt Implant deployment and with EVD remaining clamped, an ICP assessment that demonstrates: 1) ICP below 20 cmH2O as measured by the EVD with no periods longer than 15 minutes above 20 cmH2O; and 2) No episodes of ICP, measured by EVD, above 25 cmH2O with associated subject symptoms
Time Frame
36-48 hours following eShunt Implant deployment
Secondary Outcome Measure Information:
Title
Number of subjects requiring conversion to conventional CSF shunt
Description
Evaluate the need for CSF diversion by conventional CSF shunt insertion within the 24 months following eShunt Implant deployment
Time Frame
24 months following eShunt Implant deployment
Title
Incidence of clinically significant abnormal laboratory test results
Description
Clinically significant changes from baseline laboratory test results will be summarized
Time Frame
24 months following eShunt Implant deployment
Title
Incidence of clinically significant changes from baseline MRI imaging
Description
Clinically significant changes from baseline MRI images will be summarized
Time Frame
24 months following eShunt Implant deployment
Title
Incidence of clinically significant changes from baseline CT imaging
Description
Clinically significant changes from baseline CT images will be summarized
Time Frame
24 months following eShunt Implant deployment
Other Pre-specified Outcome Measures:
Title
Safety Endpoint: serious adverse events (SAEs)
Description
Evaluate for any device or procedure related serious adverse events (SAEs)
Time Frame
24 months following eShunt Implant deployment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ona Whelove
Phone
4155152885
Email
clinicaltrials@cerevasc.com
First Name & Middle Initial & Last Name or Official Title & Degree
DJ Cass
Email
clinicaltrials@cerevasc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro M Lylyk, MD
Organizational Affiliation
Clinica Sagrada Familia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica La Sagrada Familia
City
Buenos Aires
State/Province
Ciudad A. De Buenos Aires
ZIP/Postal Code
C1426B
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Toranzo
Email
ctoranzo@lylyk.com.ar

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30626626
Citation
Heilman CB, Basil GW, Beneduce BM, Malek AM. Anatomical characterization of the inferior petrosal sinus and adjacent cerebellopontine angle cistern for development of an endovascular transdural cerebrospinal fluid shunt. J Neurointerv Surg. 2019 Jun;11(6):598-602. doi: 10.1136/neurintsurg-2018-014445. Epub 2019 Jan 9.
Results Reference
background
PubMed Identifier
34862267
Citation
Lylyk P, Lylyk I, Bleise C, Scrivano E, Lylyk PN, Beneduce B, Heilman CB, Malek AM. First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt. J Neurointerv Surg. 2022 May;14(5):495-9. doi: 10.1136/neurintsurg-2021-018136. Epub 2021 Dec 3.
Results Reference
result

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

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