The purpose of this study is to assess how safe choydar flow-directed mesh stent is and how well it works in the treatment of unruptured intracranial aneurysms (a condition in which a bulging blood vessel in the brain can burst and cause bleeding) in a real-world setting.
Study Type
OBSERVATIONAL
Enrollment
200
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I)
Complete aneurysm occlusion rate as per Raymond Roy classification criteria (Class I) is defined as complete obliteration (no contrast filling in aneurysm body or neck). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation \* 100 percent (%).
Time frame: At 12 months follow-up post-procedure
Adequate Aneurysm Occlusion Rate at 12-month Follow-up Post-Procedure (Raymond-Roy Classes I and II)
Adequate aneurysm occlusion rate as per Raymond Roy classification criteria (Class II and III) is defined as Class II: residual neck (contrast filling in aneurysm neck but none in aneurysm body) and Class III: residual aneurysm (contrast filling in aneurysm body). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I/II occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation \* 100 %.
Time frame: At 12 months follow-up post-procedure
Percentage of Participants with Immediate Technical Success Rate of Procedure
Percentage of participants with immediate technical success rate of procedure will be reported. Immediate technical success of the procedure is defined as the percentage of participants in whom the flow diverter is successfully deployed during the procedure, with accurate positioning confirmed by intra-procedure angiography, and with effective coverage of the aneurysm neck by the implant. It is calculated as follows: number of participants with successful placement of the investigational device/total number of participants undergoing the treatment \* 100 %.
Time frame: At Day 0 (Day of procedure)
Re-treatment Rate of Target Aneurysm at 12-Month Follow-up Post-Procedure
The incidence of re-treatment of the target aneurysm at 12 months follow-up post-procedure will be reported.
Time frame: At 12 months follow-up post-procedure
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Percentage of Participants with Modified Rankin Scale (mRS) Score of 0-2 at 12 Months Post-Procedure
Percentage of participants with mRS score of 0-2 at 12 months post-procedure will be reported. The mRS score is issued to evaluate the improvement of neurological function. It assesses the ability of participants with neurological disease to live independently. There are 7 levels of this score, 0 points represent no symptoms of disability, higher scores mean worse prognosis of participants , and 6 points represent death.
Time frame: At 12 months follow-up post-procedure
Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During Perioperative Period
Number of participants with major ischemic/hemorrhagic events and/or death during perioperative period will be reported. Major ischemic/hemorrhagic events are defined as an increase of \>= 4 points in the National Institutes of Health Stroke Scale (NIHSS) score compared with the previous score.
Time frame: Perioperative
Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During 12-Month Follow-up
Number of participants with major ischemic/hemorrhagic events and/or death during 12 months follow-up period will be reported. Major ischemic/hemorrhagic events are defined as an increase of \>= 4 points in the NIHSS score compared with the previous score.
Time frame: At 12 months follow-up post-procedure
Number of Participants with Severe in-Stent Stenosis (Greater Than [>] 50%) During 12-Month Follow-up
Number of participants with severe in-stent stenosis during 12-month follow-up period will be reported. The percent stenosis is calculated according to the calculation method of Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study as follows: (1 - Ds \[Diameter of the artery at the site of the most severe stenosis\]/Dn \[Diameter of the normal artery\]) \* 100%.
Time frame: At 12 months follow-up post-procedure
Rupture Rate of Target Aneurysm During 12-Month Follow-Up Post-Procedure
The incidence of rupture of the target aneurysm within 12 months post-procedure will be reported.
Time frame: At 12 months follow-up post-procedure