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

NCT06386289 | Withdrawn DMC FDA Device

• 1 other identifier: CNV202202
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• First pass reperfusion

  First pass reperfusion (eTICI ≥ 2b50 without additional therapy)

  Intraprocedural

Study Arms (1)

Single Arm

EXPERIMENTAL

Mechanical Thrombectomy

Device: Cereglide 92

Interventions

Cereglide 92 DEVICE

Aspiration of cerebral large vessels occlusions

Single Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cerenovus, Part of DePuy Synthes Products, Inc.: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: September 1, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• 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