The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms.
Approximately 258 subjects with intracranial aneurysms would be enrolled for coiling embolization according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±90 days) postoperatively; subjects would underwent DSA imaging at surgery and at 12months (±90 days) postoperatively, and MRA imaging at 18 months (±90 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of Nufairy Coil Embolization System for coiling embolization for the treatment of intracranial aneurysms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
Nufairy® Coil embolization system for intracranial aneurysm
Shanghai Changhai Hospital
Shanghai, China
Successful occlusion rate of aneurysm at 12-month post-procedure.
It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization).
Time frame: 12 month
Complete occlusion rate of aneurysm at 12-month post-procedure.
The "complete occlusion rate of aneurysm" was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I (i.e., 100% aneurysm embolization).
Time frame: 12 month
Recurrence rate of aneurysm at 12-month post-procedure.
The "recurrence rate of aneurysm" was defined as the percentage of subjects with a decrease in the degree of aneurysm embolization at the follow-up visit as compared with immediately post-procedure.
Time frame: 12 month
Retreatment rate of aneurysm at 12-month post-procedure.
The "retreatment of aneurysm" was defined as the percentage of subject who received retreatment for the recurrence of target aneurysms during the follow-up period
Time frame: 12 month
Device-related serious adverse events at 1, 6, and 12 months after surgery;
Time frame: 12 month
The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 12 months.
Time frame: 12 month
The incidence of ipsilateral ischemic stroke of the target aneurysm within 12 months.
Time frame: 12 month
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