CereVasc eShunt for Normal Pressure Hydrocephalus

(STRIDE Trial)

Recruiting at 29 trial locations

Overseen By Randy Burrington

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CereVasc Inc

Must not be taking: Anticoagulants

Disqualifiers: Inability to walk, Neurodegenerative diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of the eShunt System, a new treatment option for normal pressure hydrocephalus (NPH), a condition that causes walking difficulties, memory problems, and incontinence. Participants will receive either the eShunt Implant, placed using a minimally invasive technique, or the standard ventriculo-peritoneal (VP) shunt surgery for comparison. Ideal candidates have experienced walking issues for at least three months and show symptoms typical of NPH, such as memory problems or urgency in urination. As an unphased trial, this study offers patients the opportunity to contribute to groundbreaking research in NPH treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the eShunt System, a new device for treating normal pressure hydrocephalus, has a promising safety record. In one study, patients who received the eShunt implant tolerated it well over a year, suggesting it might be safe for long-term use. Another study found that the device can be safely implanted in older adults, allowing for a quick recovery.

The eShunt System has also received the FDA Breakthrough Device Designation, indicating it could offer significant improvements over current treatments and reflecting confidence in its safety and effectiveness.

While these results are encouraging, all treatments can have risks. The ongoing trial will continue to monitor any possible side effects. Always consider consulting a healthcare provider when thinking about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the CereVasc® eShunt® System because it offers a less invasive approach to treating normal pressure hydrocephalus compared to the standard ventriculo-peritoneal (VP) shunt surgery. The eShunt System is placed endovascularly, meaning it can be inserted through blood vessels, potentially reducing surgical risks and recovery time. This innovative delivery method could make the treatment safer and more accessible, which is why the medical community is eager to see its effectiveness in action.

What evidence suggests that the eShunt System is effective for normal pressure hydrocephalus?

Research has shown that the eShunt System, which participants in this trial may receive, might help people with normal pressure hydrocephalus (NPH). In one study, 88.9% of patients showed noticeable improvement in their ability to walk after using the eShunt. This system employs a less invasive method, requiring a smaller incision and offering a shorter recovery time compared to traditional surgery. Overall, the eShunt System appears to be a promising treatment for NPH. Another treatment option in this trial is the VP Shunt, a surgical ventriculo-peritoneal shunt procedure, which serves as an active comparator. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 60 years old or older.

I can and will sign the consent form myself or have someone who can legally do it for me.

I have had trouble walking for at least 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either endovascular placement of the eShunt Implant or a surgical ventriculo-peritoneal shunt procedure

6 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of gait impairment and adverse events

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CereVasc eShunt System

How Is the Trial Designed?

Group I: eShunt System Experimental Treatment 1 Intervention

Endovascular placement of the eShunt Implant

Group II: VP Shunt Active Control 1 Intervention

Surgical ventriculo-peritoneal shunt procedure

Who Is Running the Clinical Trial?

CereVasc Inc

Lead Sponsor

Trials

5

Recruited

340+

Citations

1. cerevasc.com cerevasc.com/cerevasc-inc-announces-results-of-groundbreaking-clinical-study-of-the-eshunt-system-in-the-treatment-of-elderly-patients-with-normal-pressure-hydrocephalus/

CereVasc, Inc. Announces Results of Groundbreaking ... The results of this study show that an endovascular approach to treating NPH may improve overall care and clinical outcomes.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06498960

Study Details | NCT06498960 | Evaluation of the Safety ... The STRIDE study is a prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure ...

3. jnis.bmj.com jnis.bmj.com/content/16/Suppl_1/A29.1

O-037 One-year follow-up of the eShunt® System for ... Eight of nine (88.9%) patients exhibited gait improvement exceeding the established minimal clinically important difference (MCID) of 16.5% following ...

4. prnewswire.com prnewswire.com/news-releases/cerevasc-inc-announces-results-of-groundbreaking-clinical-study-of-the-eshunt-system-in-the-treatment-of-elderly-patients-with-normal-pressure-hydrocephalus-302368231.html

CereVasc, Inc. Announces Results of Groundbreaking ... The results of this study show that an endovascular approach to treating NPH may improve overall care and clinical outcomes.

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000206181

The eShunt® System: A Novel Minimally Invasive CSF ... A novel, minimally invasive, endovascular cerebrospinal fluid (CSF) shunting system for treatment of idiopathic Normal Pressure Hydrocephalus (iNPH).

6. jnis.bmj.com jnis.bmj.com/content/16/Suppl_1/A78.1

P-031 One-year safety of the eShunt® implant used in ... These preliminary results indicate a potentially acceptable safety profile for long-term use in the treatment of communicating hydrocephalus.

7. cerevasc.com cerevasc.com/cerevasc-inc-receives-fda-breakthrough-device-designation-for-the-eshunt-system-for-use-in-pediatric-patients/

CereVasc, Inc. Receives FDA Breakthrough Device ... The eShunt System received FDA Breakthrough Device Designation for treating communicating hydrocephalus in pediatric patients 12 and older, ...

8. clinicaltrial.be clinicaltrial.be/en/details/33018?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

US Pilot Study of the CereVasc® eShunt® System in ... The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a ...