Minimally invasive treatment for communicating hydrocephalus using an eShunt

Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc EShunt™ System in the Treatment of Communicating Hydrocephalus

This study is testing a new, less invasive treatment called the eShunt to help people with communicating hydrocephalus by draining extra fluid from their brains into their blood, specifically for those who can't stop using an external drain after a brain bleed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CereVasc Inc (Industry-sponsored)
• Locations: 1 site (Buenos Aires, Ciudad A. de Buenos Aires)
• Trial ID: NCT04758611 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the eShunt™ System, a minimally invasive method designed to treat communicating hydrocephalus by draining excess cerebrospinal fluid (CSF) into the venous system. The study will enroll up to 30 patients who have post-aneurysmal subarachnoid hemorrhage and are unable to be weaned from an external ventricular drain. Participants will undergo the eShunt Implant procedure and will be monitored with neurological evaluations and imaging at various intervals over a 24-month period. The goal is to assess the safety and effectiveness of this new treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with post-aneurysmal subarachnoid hemorrhage and symptomatic communicating hydrocephalus who cannot be weaned from an external ventricular drain.

Not a fit: Patients with severe vasospasm or those who do not meet the specific anatomical and clinical criteria for the eShunt Implant may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for patients suffering from communicating hydrocephalus, potentially improving their quality of life.

How similar studies have performed: While the eShunt System represents a novel approach, similar minimally invasive techniques for treating hydrocephalus have shown promise in other studies.

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.)

Where this trial is running

Buenos Aires, Ciudad A. de Buenos Aires

• Clínica La Sagrada Familia — Buenos Aires, Ciudad A. de Buenos Aires, Argentina (Recruiting)

Study contacts

• Principal investigator: Pedro M Lylyk, MD — Clinica Sagrada Familia
• Study coordinator: Ona Whelove

Conditions Hydrocephalus, Communicating; Hydrocephalus; eShunt