NeVa Retrospective Comparative SR Study

Launched by VESALIO · Apr 30, 2025

Keywords

ClinConnect Summary

The NeVa Retrospective Comparative SR Study is a clinical trial designed to compare two types of stent retrievers used to treat strokes caused by blockages in large blood vessels. Specifically, it will look at how effective the NeVa Stent Retriever is compared to a Control Stent Retriever in helping to reopen blood vessels in the brain. The main goals of the study are to see how often each device successfully restores blood flow and to evaluate their safety.

To participate in this trial, individuals must be at least 18 years old and have experienced a specific type of stroke with certain severity levels. They should have started treatment within 8 hours of their last known well time. Participants will be monitored for how well the stent retrievers work and any side effects they might experience during the treatment. This study is not yet recruiting participants, so it’s important to stay informed about when it will begin and if you or a loved one may qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Treatment during the enrollment period
• • Age ≥18
• • Baseline modified Thrombolysis in Cerebral Infarction (mTICI) score ≤ 1
• • Pre-stroke modified Rankin score (mRS) of 0 or 1
• • Internal Carotid Artery (ICA), Middle Cerebral Artery (first segment M1/ second segment M2), basilar artery or vertebral artery occlusion
• • National Institutes of Health Stroke Scale (NIHSS) score ≥ 8 and ≤ 25
• • Thrombectomy procedure initiated within 8h of Time Last Known Well (TLKW)
• • Intravenous Tissue Plasminogen Activator (IV-tPA) failed, given within 3h of TLKW, or ineligibility for thrombolytic drug
• Exclusion Criteria:
• • First line contact aspiration alone or non-study device as first-line device