Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062688) titled 'Outcomes of Gamma Knife Radiosurgery Followed by Feeder Embolization for Hemorrhagic Medium-Sized 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

Condition: Condition - Hemorrhagic medium-sized cerebral arteriovenous malformation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety and efficacy of feeder embolization following single-session stereotactic radiosurgery (SRS) for hemorrhagic medium-sized cerebral arteriovenous malformations by assessing reduction in hemorrhage rate, hemorrhage volume, and mortality risk, as well as shortening of the time to complete obliteration and improvement in the obliteration rate. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Single-session Gamma Knife stereotactic radiosurgery (SRS) is performed for hemorrhagic medium-sized cerebral arteriovenous malformations, followed, if possible within 1 month, by a single session of feeder embolization using a liquid embolic agent or coils. The SRS margin dose is 17-20 Gy.

Eligibility: Age-lower limit - 18 years-old 1.5) 7. Pregnant or breastfeeding patients 8. Patients enrolled in another clinical trial, including a trial involving an investigational drug 9. Patients with a known allergy to iodinated contrast media 10. Patients with multiple AVMs 11. Patients diagnosed with vein of Galen malformation, cavernous malformation, dural arteriovenous fistula, venous malformation, or a neurocutaneous syndrome such as von Hippel-Lindau disease, Sturge-Weber syndrome, or Wyburn-Mason syndrome 12. Patients with an AVM associated with moyamoya-type changes or hereditary hemorrhagic telangiectasia (Osler-Weber-Rendu syndrome) 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=R000071773

Disclaimer: Curated by HT Syndication.