Last updated on February 2018

Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent


Brief description of study

This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year.

Detailed Study Description

This study is a prospective multi-centre observational single-arm clinical trial, aiming to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents combined with coils for the treatment of ruptured intracranial saccular aneurysms. As the protocol, clinical follow-up at 30 days (7 days) after procedure, DSA or MRA follow-up at 6 months (30 days) after procedure, and clinical follow-up at 1 year (30 days) after procedure was conducted for each patient. The primary end-points include major adverse events (cerebral infarct and death) in 30 days post-procedure, complete occlusion rate at 6 months (18030d) follow-up, and modified Rankin Score (mRS) at 1 year follow-up. The secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (18030d) follow-up and in-stent stenosis or obliteration rate at 6 months (18030d) follow-up. Duration of this study is 2 years.

Clinical Study Identifier: NCT02830386

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