Acute Ischemic StrokeSPLENDIDNCT06386289
Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke
A study testing Cereglide 92 in people with Acute Ischemic Stroke, run by Cerenovus, Part of DePuy Synthes Products, Inc..
Trial summary
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Cereglide 92
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute ischemic stroke.
- NIHSS ≥6
- Baseline mRS ≤ 2
- Completed informed consent.
Who cannot join
- Known pregnancy.
- Life expectancy less than 90 days prior to stroke onset.
- Known Diagnosis of Dementia
- Treatment with heparin within 48 hours.
- Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
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- Baseline CT or MRI showing mass effect
- Concurrent sino-venous thrombosis
- Currently participating in an investigational (drug, device, etc.) clinical trial, excluding trials in observational, natural history, and/or epidemiological studies not involving intervention and that will not confound study endpoints. Sponsor approval is required.
About this study
Official title: Safety, Performance and Lesion Evaluation of Neurothrombectomy Using CEREGLIDE 92 Intermediate Catheter: A Prospective Multi-Center Single-Arm IDE Trial (SPLENDID)
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease
- Conditions
- Acute Ischemic Stroke
- Being tested
- Cereglide 92
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereglide 92Device
Aspiration of cerebral large vessels occlusions
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Mechanical Thrombectomy Receives: Device: Cereglide 92 |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass reperfusion
First pass reperfusion (eTICI ≥ 2b50 without additional therapy)
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Sep 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Why it stopped: Due to a change in innovation strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Froehler, MD, PhD, Principal investigator, Vanderbilt University Medical CenterBrian Jankowitz, MD, Principal investigator, JFK University Medical CenterAnsaar Rai, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386289
- Sponsor's protocol ID
- CNV202202
- Other IDs
- CNV202202
- Acronym
- SPLENDID
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA)
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Performance and Lesion Evaluation of Neurothrombectomy Using CEREGLIDE 92 Intermediate Catheter: A Prospective Multi-Center Single-Arm IDE Trial (SPLENDID)
- ClinicalTrials.gov ID
- NCT06386289
- Acronym / sponsor ID
- SPLENDID / CNV202202
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a change in innovation strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Cereglide 92Mechanical Thrombectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of acute ischemic stroke.
- NIHSS ≥6
- Baseline mRS ≤ 2
- Completed informed consent.
Key exclusion criteria (9 listed)
- Known pregnancy.
- Life expectancy less than 90 days prior to stroke onset.
- Known Diagnosis of Dementia
- Treatment with heparin within 48 hours.
- Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cereglide 92Aspiration of cerebral large vessels occlusions | Device | Single Arm |
Primary outcome
First pass reperfusion
Time frame: Intraprocedural
First pass reperfusion (eTICI ≥ 2b50 without additional therapy)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Froehler, MD, PhD principal investigator
Vanderbilt University Medical Center
Brian Jankowitz, MD principal investigator
JFK University Medical Center
Ansaar Rai, MD principal investigator
West Virginia University
Questions about this trial
What is this clinical trial studying?
A study testing Cereglide 92 in people with Acute Ischemic Stroke, run by Cerenovus, Part of DePuy Synthes Products, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pass reperfusion (time frame: Intraprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.