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Published in: BMC Neurology 1/2022

Open Access 01-12-2022 | Ruptured Aneurysm | Study protocol

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

Authors: Gaozhi Li, Yongquan Han, Shenghao Ding, Yaohua Pan, Xiaohua Zhang, Bing Zhao

Published in: BMC Neurology | Issue 1/2022

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Abstract

Background

Stent-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.

Methods

This 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.

Discussion

We 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 registration

Chinese Clinic Trial Registry: ChiCTR2000036972​; Registration date: Aug 26, 2020
Literature
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go back to reference Xue G, Zuo Q, Tang H, Zhang X, Duan G, Feng Z, et al. Comparison of low-profiled visualized intraluminal support stent-assisted coiling and coiling only for acutely ruptured intracranial aneurysms: safety and efficacy based on a propensity score-matched cohort study. Neurosurgery. 2020;87(3):584–91. https://doi.org/10.1093/neuros/nyaa110.CrossRefPubMed Xue G, Zuo Q, Tang H, Zhang X, Duan G, Feng Z, et al. Comparison of low-profiled visualized intraluminal support stent-assisted coiling and coiling only for acutely ruptured intracranial aneurysms: safety and efficacy based on a propensity score-matched cohort study. Neurosurgery. 2020;87(3):584–91. https://​doi.​org/​10.​1093/​neuros/​nyaa110.CrossRefPubMed
Metadata
Title
Stent-assisted coiling of acutely ruptured cerebral aneurysm: a multicenter prospective registry study (SAVE)
Authors
Gaozhi Li
Yongquan Han
Shenghao Ding
Yaohua Pan
Xiaohua Zhang
Bing Zhao
Publication date
01-12-2022
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2022
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/s12883-022-02800-4

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