Clinical Trial

NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization

Study acronym: NOVA
Recruiting
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Summary
The goal of this clinical trial is to evaluate whether non-invasive continuous blood pressure monitoring (NVBP) using the ClearSight system can safely serve as an alternative to radial arterial catheterization for invasive arterial blood pressure monitoring (IABP) in patients undergoing coil embolization for unruptured intracranial aneurysms. The main questions it aims to answer are: * Does NVBP monitoring detect intraoperative hypotension and hypertension events with similar reliability compared to IABP? * Does NVBP monitoring reduce the need for invasive arterial catheterization without compromising patient safety or clinical outcomes? Researchers will compare patients assigned to NVBP monitoring with those receiving conventional IABP monitoring. Participants will: * Be randomly assigned to NVBP monitoring or standard IABP monitoring during coil embolization. * Receive continuous monitoring of cerebral oxygenation with near-infrared spectroscopy (rSO₂). * Undergo standard anesthesia induction, maintenance, and postoperative intensive care protocols. * Have their intraoperative hemodynamic events, vasopressor use, and postoperative outcomes recorded up to 30 days after the procedure.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-17.
Status change: Not Yet Recruiting → Recruiting 2026-04-06
Trial Details
NCT Number NCT07246148
Lead Sponsor Korea University Anam Hospital
Conditions Cerebral Aneurysms, Intracranial Aneurysms, Coil Embolization, Hemodynamic Instability, Noninvasive Cardiac Monitoring
Enrollment 50 participants
Start Date 2026-01-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-09