Transvenous embolization for intracranial arteriovenous malformations: study protocol for a prospective, single-center cohort trial

Abstract

Background and objectives: In 2010, Nguyen et al. reported a novel method for the treatment of intracranial arteriovenous malformations by transvenous embolization combined with conventional treatment. At present, although the outcome of this approach is generally good, most studies are case reports, and there is a lack of prospective cohort study for assessing the effectiveness of this method. Therefore, in this clinical trial protocol, we will assess the efficacy of transvenous embolization of draining venous unit, with the aim of helping to optimize treatment strategies for patients with intracranial arteriovenous malformations. Design: This is a prospective, single-center cohort study. Methods: We will recruit 190 patients with intracranial arteriovenous malformations from the Department of Intracranial Arteriovenous Malformation, Henan Provincial People's Hospital, China. The patients will be assigned to two groups. Participants in the control group (n = 95) will undergo conventional treatment, such as surgery, stereotactic radiosurgery and transarterial embolization. Participants in the trial group (n = 95) will receive transvenous embolization combined with conventional treatment. Outcome measures: The primary outcome measures are stroke or death within 30 days of surgery, and efficacy of treatment at 6 months postoperatively. The secondary outcome measures are the efficacy of treatment at 30 days and 24 months postoperatively, National Institutes of Health Stroke Scale scores, modified Rankin Scale scores at 1, 7 and 30 days and 3, 6, 12, 24 and 36 months postoperatively, and adverse reactions during treatment and follow-up. Discussion: Our study will provide clinical evidence for the rational use of transvenous embolization for intracranial arteriovenous malformations. Ethics and dissemination: This trial has been approved by the Medical Ethics Committee of Henan Provincial People's Hospital of China [approval number: 2017 (41)]. This trial was designed in 1 August 2017. Ethics approval was completed in 19 October 2017. This trial was registered in 11 December 2017. The recruitment of participants began in January 2018. The recruitment will be finished in January 2019. Follow-up will be completed in January 2022. Data analysis will be finished in January 2023. Trial registration: This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-OOC-17013851). Protocol version (1.0).