Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063247) titled 'Study of blood flow changes measured by transcranial Doppler ultrasonography after flow diverter treatment for intracranial aneurysms' on Oct. 15.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Ichinomiya Nishi Hospital
Condition:
Condition - Intracranial aneurysm
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To characterize longitudinal changes in middle cerebral artery blood flow velocity measured by transcranial Doppler ultrasonography before and after flow diverter placement and to explore their associations with postoperative clinical findings, imaging findings, and hemorrhagic and ischemic complications.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Transcranial Doppler ultrasonography is performed before flow diverter placement (the preceding day), immediately after the procedure, on postoperative day 1, and during subsequent hospitalization. The bilateral middle cerebral arteries are assessed when feasible. Brain MRI is performed on postoperative day 1 and repeated if new symptoms or other clinical changes occur during follow-up. Flow diverter placement is clinically planned; no research-based allocation of treatment is described.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients scheduled for flow diverter placement for an intracranial aneurysm.
Patients who provide consent to participate in the study
Key exclusion criteria - Patients in whom blood flow velocity in the target vessel cannot be measured using transcranial Doppler ultrasonography.
Patients considered unsuitable for study participation by the principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 10 Month 01 Day
Anticipated trial start date - 2026 Year 10 Month 19 Day
Last follow-up date - 2026 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072305
Disclaimer: Curated by HT Syndication.