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NCT06386289 Clinical Trial

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

Acute Ischemic Stroke Clinical Trial

— SPLENDID  

Official title:
Safety, Performance and Lesion Evaluation of Neurothrombectomy Using CEREGLIDE 92 Intermediate Catheter: A Prospective Multi-Center Single-Arm IDE Trial (SPLENDID)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06386289
Other study ID # CNV202202
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date June 30, 2026

Study information
Verified date June 2024
Source Cerenovus, Part of DePuy Synthes Products, Inc.
Contact Study Contact
Phone +1(206)419-7930
Email SPLENDID@ITS.JNJ.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 172
Est. completion date June 30, 2026
Est. primary completion date February 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cereglide 92
Aspiration of cerebral large vessels occlusions

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio
United States JFK Medical Center Edison New Jersey
United States University of Texas Houston Houston Texas
United States University of Iowa Hospital & Clinics Iowa City Iowa
United States West Virginia University Morgantown West Virginia
United States Vanderbilt University Medical Center Nashville Tennessee
United States Allegheny General Hospital of Research Pittsburgh Pennsylvania
United States Texas Stroke Institute Plano Texas
United States Oregon Health And Science University Portland Oregon
United States University of Utah Salt Lake City Utah
United States Mercy Health St Vincent Medical Center Toledo Ohio
United States Westchester Medical Center Valhalla New York

Sponsors (1)
Lead Sponsor Collaborator
Cerenovus, Part of DePuy Synthes Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary First pass reperfusion First pass reperfusion (eTICI = 2b50 without additional therapy) Intraprocedural
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