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

Launched by CERENOVUS, PART OF DEPUY SYNTHES PRODUCTS, INC. · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a device called the CEREGLIDE 92 Intermediate Catheter, which is used to treat people who are having an acute ischemic stroke. An acute ischemic stroke happens when a blood vessel in the brain is blocked, preventing blood from reaching part of the brain. The trial is aimed at patients who are diagnosed with this type of stroke and have certain symptoms that meet specific criteria, like a certain score on the NIH Stroke Scale and a certain level of disability before their stroke.

To participate in this trial, individuals must be between the ages of 18 and 89 and have had a recent stroke that meets the study's guidelines. However, some people may not be eligible, such as those who are pregnant, have a very short life expectancy, or have certain other medical conditions. If someone qualifies and chooses to participate, they will be closely monitored during the trial to see how well the device works and if it is safe to use. It’s important to know that the trial is not yet recruiting participants, which means they are still in the planning phase.

Gender

ALL

Eligibility criteria

• 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.