Safety, Performance of CEREGLIDE 92 Intermediate Catheter... | NCT06386289

Studies
Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke

NCT06386289

Sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Status

Withdrawn

Last Update Posted

Sep 2, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Acute Ischemic Stroke

Interventions

Cereglide 92

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CNV202202	Other Identifier	Cerenovus, Part of DePuy Synthes Products, Inc.

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to a change in innovation strategy

Expanded Access Info

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Feb 28, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Apr 23, 2024

First Submission Date that Met QC Criteria

Apr 23, 2024

First Posted Date

Apr 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2025

Last Update Posted Date

Sep 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	Mechanical Thrombectomy	Device: Cereglide 92

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cereglide 92	Device	Aspiration of cerebral large vessels occlusions	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First pass reperfusion	First pass reperfusion (eTICI ≥ 2b50 without additional therapy)	Intraprocedural

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of acute ischemic stroke.
NIHSS ≥6
Baseline mRS ≤ 2
Completed informed consent.

Exclusion Criteria:

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.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Froehler, MD, PhD	Vanderbilt University Medical Center	Principal Investigator
Brian Jankowitz, MD	JFK University Medical Center	Principal Investigator
Ansaar Rai, MD	West Virginia University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA)

Types

Not provided

Time Frame

Not provided

Access Criteria

Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

URL

http://yoda.yale.edu

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided