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Procedure
CEREGLIDE 92 Catheter for Ischemic Stroke (SPLENDID Trial)
N/A
Waitlist Available
Led By Brian Jankowitz, MD
Research Sponsored by Cerenovus, Part of DePuy Synthes Products, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of acute ischemic stroke
Baseline mRS ≤ 2
Must not have
Concurrent sino-venous thrombosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraprocedural
Awards & highlights
No Placebo-Only Group
Summary
This trial involves a device that is used to help patients with a severe type of stroke caused by blockages in the large blood vessels in the brain.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, similar procedures may include risks such as bleeding at the catheter insertion site, possible allergic reactions to materials used in the device, vessel damage during revascularization attempts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a stroke caused by a blood clot.
Select...
I can carry out all my usual duties without assistance.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a blood clot in the veins of my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraprocedural
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraprocedural
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
First pass reperfusion
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Mechanical Thrombectomy
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Who is running the clinical trial?
Cerenovus, Part of DePuy Synthes Products, Inc.Lead Sponsor
8 Previous Clinical Trials
5,399 Total Patients Enrolled
3 Trials studying Stroke
4,102 Patients Enrolled for Stroke
Brian Jankowitz, MDPrincipal InvestigatorJFK University Medical Center
4 Previous Clinical Trials
589 Total Patients Enrolled
2 Trials studying Stroke
121 Patients Enrolled for Stroke
Michael Froehler, MD, PhDPrincipal InvestigatorVanderbilt University Medical Center
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