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

140 Participants Needed

Trial Summary

What is the purpose of this trial?

The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease

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 data supports the effectiveness of the treatment Cereglide 92 for ischemic stroke?

The research on carotid endarterectomy (a surgical procedure to remove blockages in the carotid artery) shows it can help prevent further strokes and improve outcomes in patients with acute ischemic stroke. This suggests that treatments targeting blood flow in the brain, like Cereglide 92, might also be effective. ^{1 2 3 4 5}

Is the CEREGLIDE 92 Catheter generally safe for use in humans?

There is no specific safety data available for the CEREGLIDE 92 Catheter, but general safety concerns with catheters include adverse events like infections and phlebitis (inflammation of a vein). Further research is needed to determine its safety specifically. ^{6 7 8 9 10}

How does the CEREGLIDE 92 Catheter treatment for ischemic stroke differ from other treatments?

The CEREGLIDE 92 Catheter is a novel large bore aspiration catheter designed for the endovascular treatment of acute ischemic stroke, which differs from traditional drug therapies like alteplase by mechanically removing the blood clot rather than dissolving it with medication. ^{11 12 13 14 15}

Research Team

Ansaar Rai, MD

Principal Investigator

West Virginia University

Michael Froehler, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Brian Jankowitz, MD

Principal Investigator

JFK University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Results of carotid endarterectomy in the acutest period of ischemic stroke]. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Urgent carotid endarterectomy in patients with recent/crescendo transient ischaemic attacks or acute stroke. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Urgent carotid endarterectomy to prevent recurrence and improve neurologic outcome in mild-to-moderate acute neurologic events. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Benefit of carotid endarterectomy after prior stroke. [2019]

5. China pubmed.ncbi.nlm.nih.gov

Outcome of catheter ablation of atrial fibrillation in patients with prior ischemic stroke. [2013]

6. Switzerland 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. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Carotid endarterectomy following thrombolysis for acute ischaemic stroke. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Catheter Ablation for Atrial Fibrillation in Patients With Prior Cerebrovascular Events. [2021]

9. Denmark pubmed.ncbi.nlm.nih.gov

Neurologic safety event rates in the SENTIS trial control population. [2013]

10. China pubmed.ncbi.nlm.nih.gov

[Analysis of Adverse Events in Clinical Use of Catheter]. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Prospective, Multicenter, Single-Group Target-Value Clinical Trial to Evaluate the Safety and Efficacy of a Large Bore Aspiration Catheter System for the Endovascular Treatment of Acute Ischemic Stroke. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Thrombectomy for acute internal carotid thrombosis: five thrombectomy devices compared. [2012]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological and non-pharmacological recanalization strategies in acute ischemic stroke. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Orion, an improved balloon on a wire system: initial experience. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Relay-balloon technique for recanalization of acute symptomatic proximal internal carotid artery occlusion with short balloon-tipped guiding catheter landing zone. [2018]