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Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

Primary Purpose

Hydrocephalus, Normal Pressure, Hydrocephalus

Status

Recruiting

Phase

Not Applicable

Locations

Argentina

Study Type

Interventional

Intervention

eShunt Implant

About this trial

This is an interventional treatment trial for Hydrocephalus, Normal Pressure focused on measuring eShunt, Minimally invasive shunt, Endovascular shunt

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation
Patient is able and willing to provide written informed consent
History or evidence of gait impairment duration ≥6 months
Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with:
1. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans Index >0.3) and the absence of severe hippocampal atrophy
2. Pre-procedure spinal tap test with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
3. CSF opening pressure ≥10 cmH2O
4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC
Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC

Exclusion Criteria:

Unable to walk 10 meters (33 feet) with or without an assistive device
Conditions impairing gait that are considered to be unrelated to hydrocephalus
Signs or symptoms of obstructive hydrocephalus
Active systemic infection or infection detected in CSF
Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
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
Stroke or transient ischemic attack within 180 days of eShunt Procedure
Presence of a deep vein thrombosis superior to the popliteal vein
International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)
Presence of a posterior fossa tumor or mass
Life expectancy < 1 year
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
Pregnant or planning to become pregnant
Unwilling or unable to comply with follow-up requirements

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

Device and/or procedure-related serious adverse events (SAEs)

Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)

Secondary Outcome Measures

Number of participants with abnormal MRI findings

Number of participants with abnormal MRI findings and descriptive summaries of findings

Number of participants with abnormal CT findings

Number of participants with abnormal CT findings and descriptive summaries of findings

Number of participants with clinically significant abnormal complete blood count (CBC) results

Number of participants with clinically significant abnormal results and descriptive summaries of CBC results

Number of participants with clinically significant abnormal blood chemistry results

Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results

Number of participants with clinically significant abnormal neurological exam findings

Number of participants with clinically significant abnormal findings and descriptive summaries of neurological exam finding

Number of participants with adverse events

Tabulation of all adverse events

Change in gait compared to baseline

Change in gait compared to baseline as measured by the duration in seconds of the Timed Up and Go Test (shorter durations indicate improvement (increased mobility))

Change in cognitive ability compared to baseline

Change in cognitive ability compared to baseline as measured by Montreal Cognitive Assessment (MoCA) scores (scores range from 0-30; higher scores indicate improvement (less cognitive disability))

Change in urinary symptoms compared to baseline

Change in urinary symptoms compared to baseline as measured by the Neurogenic Bladder Symptom Score (NBSS) (scores range from 0-28; lower scores indicate improvement (fewer symptoms))

Change in Modified Rankin Scale compared to baseline

Change in degree of disability compared to baseline as measured by Modified Rankin Scale (mRS) scores (scores range from 0-6; lower scores indicate improvement (less disability))

Full Information

NCT ID

NCT05250505

First Posted

February 11, 2022

Last Updated

July 7, 2023

Sponsor

CereVasc Inc

Collaborators

AlvaMed, Inc., Simplified Clinical Data Systems, LLC, Bioscience Consulting, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05250505

Brief Title

Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

Official Title

Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 10, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CereVasc Inc

Collaborators

AlvaMed, Inc., Simplified Clinical Data Systems, LLC, Bioscience Consulting, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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 includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.

Detailed Description

This is a prospective, non-randomized, open-label, single-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional CSF shunt implant is indicated. Up to 30 subjects will receive the eShunt Implant at one investigational site. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months for five years post-implantation. The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients. Subjects will be followed long-term; primary analysis results will be used to support additional studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hydrocephalus, Normal Pressure, Hydrocephalus

Keywords

eShunt, Minimally invasive shunt, Endovascular shunt

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single group assignment

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

Intervention Description

The eShunt System consists of endovascular delivery componentry and a permanent implant intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system in adults.

Primary Outcome Measure Information:

Title

Device and/or procedure-related serious adverse events (SAEs)

Description

Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)

Time Frame

90 days following eShunt Implant deployment

Secondary Outcome Measure Information:

Title

Number of participants with abnormal MRI findings

Description

Number of participants with abnormal MRI findings and descriptive summaries of findings

Time Frame

90 days following eShunt Implant deployment

Title

Number of participants with abnormal CT findings

Description

Number of participants with abnormal CT findings and descriptive summaries of findings

Time Frame

90 days following eShunt Implant deployment

Title

Number of participants with clinically significant abnormal complete blood count (CBC) results

Description

Number of participants with clinically significant abnormal results and descriptive summaries of CBC results

Time Frame

90, 180 and 365 days following eShunt Implant deployment

Title

Number of participants with clinically significant abnormal blood chemistry results

Description

Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results

Time Frame

90, 180 and 365 days following eShunt Implant deployment

Title

Number of participants with clinically significant abnormal neurological exam findings

Description

Number of participants with clinically significant abnormal findings and descriptive summaries of neurological exam finding

Time Frame

90, 180 and 365 days following eShunt Implant deployment and at study completion

Title

Number of participants with adverse events

Description

Tabulation of all adverse events

Time Frame

90, 180 and 365 days following eShunt Implant deployment and at study completion

Title

Change in gait compared to baseline

Description

Change in gait compared to baseline as measured by the duration in seconds of the Timed Up and Go Test (shorter durations indicate improvement (increased mobility))

Time Frame

90, 180 and 365 days following eShunt Implant deployment

Title

Change in cognitive ability compared to baseline

Description

Change in cognitive ability compared to baseline as measured by Montreal Cognitive Assessment (MoCA) scores (scores range from 0-30; higher scores indicate improvement (less cognitive disability))

Time Frame

90, 180 and 365 days following eShunt Implant deployment

Title

Change in urinary symptoms compared to baseline

Description

Change in urinary symptoms compared to baseline as measured by the Neurogenic Bladder Symptom Score (NBSS) (scores range from 0-28; lower scores indicate improvement (fewer symptoms))

Time Frame

90, 180 and 365 days following eShunt Implant deployment

Title

Change in Modified Rankin Scale compared to baseline

Description

Change in degree of disability compared to baseline as measured by Modified Rankin Scale (mRS) scores (scores range from 0-6; lower scores indicate improvement (less disability))

Time Frame

90, 180 and 365 days following eShunt Implant deployment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation Patient is able and willing to provide written informed consent History or evidence of gait impairment duration ≥6 months Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with: Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans Index >0.3) and the absence of severe hippocampal atrophy Pre-procedure spinal tap test with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20% CSF opening pressure ≥10 cmH2O Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12 Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC Exclusion Criteria: Unable to walk 10 meters (33 feet) with or without an assistive device Conditions impairing gait that are considered to be unrelated to hydrocephalus Signs or symptoms of obstructive hydrocephalus Active systemic infection or infection detected in CSF Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus 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 Stroke or transient ischemic attack within 180 days of eShunt Procedure Presence of a deep vein thrombosis superior to the popliteal vein International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds) Presence of a posterior fossa tumor or mass Life expectancy < 1 year 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 Pregnant or planning to become pregnant Unwilling or unable to comply with follow-up requirements

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ona Whelove

Phone

4155152885

clinicaltrials@cerevasc.com

First Name & Middle Initial & Last Name or Official Title & Degree

DJ Cass

djcass@cerevasc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro Lylyk, MD

Organizational Affiliation

Clínica La 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

ctoranzo@lylyk.com.ar

12. IPD Sharing Statement

Plan to Share IPD

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

background

PubMed Identifier

24518764

Citation

Welk B, Morrow S, Madarasz W, Baverstock R, Macnab J, Sequeira K. The validity and reliability of the neurogenic bladder symptom score. J Urol. 2014 Aug;192(2):452-7. doi: 10.1016/j.juro.2014.01.027. Epub 2014 Feb 8.

Results Reference

background

PubMed Identifier

32196732

Citation

Welk B, Lenherr S, Elliott S, Stoffel J, Gomes CM, de Bessa J, Cintra LKL, Myers JB; Neurogenic Bladder Research Group. The creation and validation of a short form of the Neurogenic Bladder Symptom Score. Neurourol Urodyn. 2020 Apr;39(4):1162-1169. doi: 10.1002/nau.24336. Epub 2020 Mar 20.

Results Reference

background

PubMed Identifier

15817019

Citation

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.

Results Reference

background

PubMed Identifier

32595883

Citation

Serrano CM, Sorbara M, Minond A, Finlay JB, Arizaga RL, Iturry M, Martinez P, Heinemann G, Gagliardi C, Serra A, Magliano FC, Yacovino D, Rojas MMEY, Ruiz AS, Graviotto HG. Validation of the Argentine version of the Montreal Cognitive Assessment Test (MOCA): A screening tool for Mild Cognitive Impairment and Mild Dementia in Elderly. Dement Neuropsychol. 2020 Apr-Jun;14(2):145-152. doi: 10.1590/1980-57642020dn14-020007.

Results Reference

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Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

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