Stent-assisted coiling of acutely ruptured cerebral aneurysm: a multicenter prospective registry study (SAVE)

Abstract

BackgroundStent-assisted coiling (SAC) has been reported as a feasible and effective treatment of wide-neck cerebral aneurysms. However, the evidence of SAC of ruptured cerebral aneurysm is lacking. There are no prospective multicenter studies regarding SAC of acutely ruptured aneurysms within 72 hours after subarachnoid hemorrhage. The purpose of the study is to evaluate the safety and efficiency of SAC of acutely ruptured cerebral aneurysms.MethodsThis study is a prospective, multicenter, and observation registry of consecutive patients with acutely ruptured cerebral aneurysms treated with SAC. Acutely ruptured aneurysms were confirmed within 72 h after the onset of the syndrome. This study will enroll at least 300 patients in 7 high-volume tertiary hospitals (more than 150 cerebral aneurysms treated per year). The primary outcomes are treatment-related thromboembolic complications within 30 days of the treatment. The secondary outcomes are any hemorrhagic complications and aneurysm recurrence at 6 months of angiographic follow-up. The clinical outcomes are measured with the Modified Rankin Scale (mRS) at discharge and at the 6 months of follow-up. The favorable outcomes are defined as an mRS of grades 0 and 2.DiscussionWe will perform a prospective, multicenter, and observational registry study of consecutive patients with wide-neck acutely ruptured cerebral aneurysms to improve the safety strategy of SAC of acutely ruptured cerebral aneurysms.Trial registrationChinese Clinic Trial Registry: ChiCTR2000036972; Registration date: Aug 26, 2020