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

Cerenovus

Status: Not yet enrolling

Conditions: Acute Ischemic Stroke

Treatments: Device: Cereglide 92

Study type: Interventional

Funder types: Industry

Identifiers

NCT06386289

CNV202202

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Single Arm

Experimental group

Description:

Mechanical Thrombectomy

Treatment:

Device: Cereglide 92