This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of unruptured intracranial saccular aneurysms.
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 unruptured 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 (180±30d) follow-up. The secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (180±30d) follow-up and in-stent stenosis or obliteration rate at 6 months (180±30d) follow-up. Duration of this study is 2 years.
Study Type
OBSERVATIONAL
Enrollment
200
Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.
Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGMajor adverse events (cerebral infarct, death) in 30 days post the procedure
Major adverse events (cerebral infarct, death) in 30 days post the procedure is defined as post-procedural cerebral infarct or death caused by any reasons
Time frame: During 30 days post the procedure
Complete occlusion rate at 6 months (180±30d) follow-up
Complete occlusion at 6 months follow-up is defined as 100% occlusion of aneurysmal sac proved by DSA at 6 months follow-up
Time frame: At 6 months (180±30d) follow-up
Immediate technical success rate (successful device placement)
Immediate technical successful is defined as good apposition of stents, effective coverage of aneurysmal neck proved by post-procedural imaging examination.
Time frame: Within 24 hours postoperatively
Immediate complete occlusion rate
Immediate Raymond scale is defined as immediate angiographic result according to the simplified Raymond scale, classⅠ: complete occlusion; class Ⅱ: neck remnant; class Ⅲ: incomplete occlusion.
Time frame: Within 24 hours postoperatively
Recurrence rate at 6 months (180±30d) follow-up
Recurrence rate: defined as increased contrast filling into the aneurysmal sac compared with immediate angiographic result.
Time frame: At 6 months (180±30d) follow-up
In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up
In-stent stenosis at 6 months follow-up is defined as stenosis more than 50% proved by DSA at 6 months follow-up. In-stent occlusion or thrombosis at 6 months follow-up is defined as complete occlusion of the stent proved by DSA at 6 months follow-up.
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Time frame: At 6 months (180±30d) follow-up