Clinical Trial: A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications (Japan)

Tokyo, Dec. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060109) titled 'A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications' on Dec. 19.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - No treatment

Primary Sponsor: Institute - Fukuoka Neurosurgical Hospital

Condition: Condition - unruptured aneurysm Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In this study, we conducted a prospective, double-blind, randomized study to verify the hypothesis that flow diverter placement for unruptured cerebral aneurysms without intraoperative heparinization does not increase the risk of ischemic complications. Basic objectives2 - Bio-equivalence

Intervention: Interventions/Control_1 - A group that undergoes systemic heparinization during flow diverter or W-EB placement for unruptured cerebral aneurysms Interventions/Control_2 - Group without systemic heparinization during flow diverter or W-EB placement for unruptured cerebral aneurysms

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Cerebral aneurysms eligible for Flow diverter placement are wide-neck aneurysms with a maximum diameter of 5mm or more and a neck diameter of 4mm or more, depending on the indications for each flow diverter. They must be unruptured or ruptured for more than 42 days. Aneurysms eligible for W-EB placement are wide-neck (defined as a neck diameter of 4mm or more or a dome/neck ratio of less than 2m) intracranial aneurysms located at the bifurcation of the anterior or posterior circulation. Eligible patients are limited to non-pregnant women aged 20 years or older. Key exclusion criteria - Patients who are taking anticoagulants due to a history of atrial fibrillation, deep vein thrombosis, or other medical diseases will be excluded. Target Size - 200

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 29 Day Date of IRB - 2025 Year 10 Month 29 Day Anticipated trial start date - 2025 Year 10 Month 29 Day Last follow-up date - 2027 Year 10 Month 29 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068466

Disclaimer: Curated by HT Syndication.