CEREGLIDE 92 Catheter for Ischemic Stroke

(SPLENDID Trial)

Recruiting at 14 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.

Must not be taking: Heparin

Disqualifiers: Pregnancy, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Intraprocedural

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called Cereglide 92 to assist people with ischemic strokes, which occur when a blood clot blocks blood flow to the brain. The goal is to determine if this device can safely remove the clot and restore blood flow. This trial suits those who have recently experienced a significant stroke, provided they haven't received recent treatments like heparin (a blood thinner) or have conditions such as dementia. Participants will undergo a procedure known as mechanical thrombectomy, where the device physically removes the clot. The focus is on improving recovery by quickly reopening the affected blood vessels. As an unphased trial, this study offers participants the chance to contribute to innovative stroke treatment research.

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

The trial protocol does not specify if you need to stop taking your current medications, but you cannot have been treated with heparin within 48 hours before the trial.

What prior data suggests that the Cereglide 92 catheter is safe for revascularization in ischemic stroke patients?

Research is examining the safety of the CEREGLIDE 92 Catheter for treating strokes caused by blocked blood vessels in the brain. In a study with 50 patients, the device helped remove the blockage. All patients experienced strokes due to a large blood vessel blockage in the brain.

The study primarily checks for serious side effects, such as brain bleeding within 24 hours and any deaths within 90 days. Although specific numbers from this study were not shared, these are common safety checks for similar treatments.

As the device remains under testing, its safety in humans is under review. The focus on serious side effects indicates careful monitoring. Prospective trial participants should stay updated on any new safety findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for ischemic stroke, which typically involves medications like clot-busting drugs and procedures such as traditional mechanical thrombectomy, the Cereglide 92 Catheter offers a potentially innovative approach. This treatment is unique because it uses a specialized catheter designed to more effectively remove blood clots from the brain. Researchers are excited about this catheter because its advanced design could improve the speed and success rate of clot retrieval, potentially leading to better outcomes for stroke patients.

What evidence suggests that the Cereglide 92 catheter is effective for ischemic stroke?

Research has shown that the CEREGLIDE 92 catheter effectively treats strokes caused by blockages in large blood vessels. This device restores blood flow in the brain by removing clots that obstruct major blood vessels. In a study with 50 patients, the CEREGLIDE 92 quickly cleared these blockages, demonstrating promising results. Participants in this trial will receive treatment with the CEREGLIDE 92 catheter, which aims to improve outcomes for stroke patients by reducing brain damage and increasing recovery chances. The treatment efficiently removes clots, leading to better patient recovery. ^{1 3 5 6 7}

Who Is on the Research Team?

Michael Froehler, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Ansaar Rai, MD

Principal Investigator

West Virginia University

Brian Jankowitz, MD

Principal Investigator

JFK University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who have recently experienced an acute ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher and a modified Rankin Scale (mRS) score of 2 or lower. They must understand the study and agree to participate. Pregnant individuals, those with short life expectancy, chronic occlusions, dementia, recent hemorrhage or mass effects on imaging are excluded.

Inclusion Criteria

Completed informed consent

I have been diagnosed with a stroke caused by a blood clot.

I can carry out all my usual duties without assistance.

Exclusion Criteria

Known pregnancy

Life expectancy less than 90 days prior to stroke onset

I have a blood clot in the veins of my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mechanical thrombectomy using the CEREGLIDE 92 Intermediate Catheter for revascularization of acute ischemic stroke

Intraprocedural

Follow-up

Participants are monitored for safety and effectiveness after the thrombectomy procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cereglide 92

Trial Overview The CEREGLIDE 92 intermediate catheter is being tested for its safety and effectiveness in reopening blocked blood vessels in the brain during an acute ischemic stroke. The goal is to restore blood flow quickly to prevent further brain damage.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Mechanical Thrombectomy

Who Is Running the Clinical Trial?

Cerenovus, Part of DePuy Synthes Products, Inc.

Lead Sponsor

Trials

10

Recruited

5,600+

Published Research Related to This Trial

The review highlights an increasing trend in adverse events associated with clinical catheters, emphasizing the need for better understanding and management of these risks.

By analyzing numerous clinical studies and literature, the review aims to identify common adverse events and their causes, providing evidence to help reduce the incidence of these events and prevent serious complications during catheter use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of Adverse Events in Clinical Use of Catheter]. Yin, J., Wang, Y., Zhang, L., et al.[2018]

In the SENTIS Trial, which included 257 patients with ischemic stroke, the rates of neurological adverse events (AEs) were established, showing intracranial hemorrhage (ICnH) at 27.6%, cerebral edema at 6.6%, neurologic worsening at 18.3%, and new strokes at 4.7%.

Most neurological AEs occurred within defined timeframes, indicating that these rates can serve as benchmarks for safety assessments in future stroke trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic safety event rates in the SENTIS trial control population. Lutsep, HL., Altafullah, IM., Roberts, R., et al.[2013]

In a study of 150 stroke patients, 170 adverse events (AEs) and no-harm incidents were identified, affecting over half of the patients, highlighting the high incidence of patient harm in stroke care.

The most common AEs included ischemic strokes and urinary tract infections, with a significant portion of medication events being preventable, indicating a need for improved safety measures in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. Nowak, B., Schwendimann, R., Lyrer, P., et al.[2022]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/SVIN.04.suppl_1.015

Abstract 015: Evaluation of the CEREGLIDE 92 Catheter, a ... The purpose of the SPLENDID study is to evaluate the safety and effectiveness of CEREGLIDE 92 Catheter (largest 8F catheter designed for ...

2. jnj.com jnj.com/media-center/press-releases/johnson-johnson-medtech-launches-cereglide-92-catheter-system-for-acute-ischemic-stroke

Johnson & Johnson MedTech Launches CEREGLIDE™ 92 ... By utilizing CEREGLIDE 92 to insert aspiration catheters during thrombectomy procedures, physicians can restore blood flow in the brain by ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214751925001501

A new era in thrombectomy: the emergence of super large ... Abstract. Mechanical thrombectomy has significantly improved outcomes for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO), ...

4. jnis.bmj.com jnis.bmj.com/content/early/2025/06/10/jnis-2025-023708

Correspondence on “Bigger isn't always better: response to ... ... Cereglide 0.092 (C-92) catheter for mechanical thrombectomy (MT) in large vessel occlusions. Our study included 50 patients across 12 ...

5. researchgate.net researchgate.net/publication/388047571_Abstract_015_Evaluation_of_the_CEREGLIDE_92_Catheter_a_Novel_Super-Bore_Aspiration_Catheter_SPLENDID_Trial_Methods

Evaluation of the CEREGLIDE 92 Catheter, a Novel Super‐ ... The purpose of the SPLENDID study is to evaluate the safety and effectiveness of CEREGLIDE 92 Catheter (largest 8F catheter designed for ...

6. jnjmedtech.com jnjmedtech.com/en-US/product/cereglide-92-catheter-system-trucourse

CEREGLIDE™ 92 Catheter System with TruCourse It has been engineered based on stroke science, designed to provide optimized delivery to the M12, .092 distal access7 and visible performance11.

7. ctv.veeva.com ctv.veeva.com/study/safety-performance-of-cereglide-92-intermediate-catheter-in-treatment-of-acute-ischemic-stroke

Safety, Performance of CEREGLIDE 92 Intermediate Catheter ... Known pregnancy. · Life expectancy less than 90 days prior to stroke onset. · Known Diagnosis of Dementia · Treatment with heparin within 48 hours.