Acute Ischemic Stroke
Conditions
Brief summary
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease
Interventions
DEVICECereglide 92
Aspiration of cerebral large vessels occlusions
Sponsors
Cerenovus, Part of DePuy Synthes Products, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First pass reperfusion | Intraprocedural | First pass reperfusion (eTICI ≥ 2b50 without additional therapy) |
Outcome results
None listed