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

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

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

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.