Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062686) titled 'A Study of the Safety and Treatment Outcomes of Feeder Artery Embolization after Volume-Staged Gamma Knife Treatment for Large Cerebral Arteriovenous Malformations' on Aug. 25.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Dokkyo Medical University Hospital

Condition: Condition - Large cerebral arteriovenous malformation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the safety and efficacy of feeder artery embolization following volume-staged Gamma Knife radiosurgery (GKRS) for large cerebral arteriovenous malformations, with particular focus on reducing hemorrhage during the latency period, shortening the time to complete obliteration, and improving the obliteration rate. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Patients with large cerebral arteriovenous malformations (nidus volume >=10 cm3) undergo volume-staged stereotactic radiosurgery (SRS) using Gamma Knife. The AVM nidus is divided into approximately two equal target volumes and treated in two stages, generally 3 months apart, with a marginal dose of 17-20 Gy at each stage. After completion of the second SRS stage, feeder artery embolization is performed in a single session, preferably within 1 month, under general anesthesia. A liquid embolic agent such as NBCA and/or coils is used to reduce AVM blood flow by occluding major feeding arteries. Intentional nidus embolization is avoided. Embolization of multiple feeders is permitted when considered safe.

Eligibility: Age-lower limit - 18 years-old 1.5. Pregnancy or breastfeeding. Enrollment in another clinical trial, including a clinical trial involving an investigational drug. Known allergy to iodinated contrast media. Multiple AVMs. Vein of Galen malformation, cavernous malformation, dural arteriovenous fistula, venous malformation, or neurocutaneous syndromes such as von Hippel-Lindau disease, Sturge-Weber syndrome, or Wyburn-Mason syndrome. AVM associated with moyamoya-type changes or hereditary hemorrhagic telangiectasia. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 01 Month 21 Day Date of IRB - 2025 Year 02 Month 21 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071772

Disclaimer: Curated by HT Syndication.