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

NCT ID: NCT06386289

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Mechanical Thrombectomy

Group Type EXPERIMENTAL

Cereglide 92

Intervention Type DEVICE

Aspiration of cerebral large vessels occlusions

Interventions

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Cereglide 92

Aspiration of cerebral large vessels occlusions

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cerenovus, Part of DePuy Synthes Products, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Froehler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Brian Jankowitz, MD

Role: PRINCIPAL_INVESTIGATOR

JFK University Medical Center

Ansaar Rai, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Other Identifiers

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CNV202202

Identifier Type: OTHER

Identifier Source: secondary_id

CNV202202

Identifier Type: -

Identifier Source: org_study_id

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