Prospective, Open-Label, Multi-Center Procedural Data Collection Case Registry on NeVa VS for Cerebral Vasospasm Management in Post Subarachnoid Hemorrhage Patients (The DILATE Registry)

What this Trial Is About

This research aims to collect and evaluate data on the use of the NeVa VS, a cerebral artery dilation device approved under Humanitarian Device Exemption (HDE), in patients experiencing symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH). The study is observational and involves multiple centers to gather procedural information on this device in a real-world setting. Participants in this study have undergone a vessel dilation procedure using the NeVa VS device on affected arteries such as the internal carotid artery, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, or basilar artery. The study tracks the diameter improvement of the targeted vessel within one hour after the NeVa VS procedure is performed. During the study, participants' vessel diameters will be closely monitored up to one hour post-procedure to assess the device's impact. The study relies on observational data collection without altering usual care and involves informed consent obtained within 72 hours after the procedure. Participants are followed to document outcomes related to cerebral vasospasm management post-subarachnoid hemorrhage.

Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts