Intracranial Aneurysm
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Johnson & Johnson Medical (Shanghai) Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants meeting all the following inclusion criteria will be included: Preoperative inclusion criteria: * Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA) prior to surgery, wide-neck (neck width greater than or equal to \[\>=\] 4 millimeters \[mm\] or dome-to-neck ratio less than \[\<\] 2) saccular or fusiform aneurysms, and the parent artery diameter must be \>= 2.0 mm and less than or equal to \[\<=\] 6.0 mm * Participants and/or their authorized representatives understand the purpose of the study, and are willing to voluntarily participate in the study and sign the informed consent form (ICF) * Prior to enrollment, a clinical decision has already been made to use the choydar flow-directed mesh stent * Participants who are willing and able to return for all follow-up visits as required by the study protocol Intraoperative inclusion criteria: \- Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by DSA during the procedure, wide-neck (neck width \>= 4 mm or dome-to-neck ratio \<2) saccular or fusiform aneurysms, and the parent artery diameter must be \>= 2.0 mm and \<= 6.0 mm
Exclusion criteria
Participants meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I) | At 12 months follow-up post-procedure | 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 (%). |
| Adequate Aneurysm Occlusion Rate at 12-month Follow-up Post-Procedure (Raymond-Roy Classes I and II) | At 12 months follow-up post-procedure | 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 %. |
| Percentage of Participants with Immediate Technical Success Rate of Procedure | At Day 0 (Day 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 %. |
| Re-treatment Rate of Target Aneurysm at 12-Month Follow-up Post-Procedure | At 12 months follow-up post-procedure | The incidence of re-treatment of the target aneurysm at 12 months follow-up post-procedure will be reported. |
| Percentage of Participants with Modified Rankin Scale (mRS) Score of 0-2 at 12 Months Post-Procedure | At 12 months follow-up 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. |
| Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During Perioperative Period | Perioperative | 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. |
| Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During 12-Month Follow-up | At 12 months follow-up post-procedure | 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. |
| Number of Participants with Severe in-Stent Stenosis (Greater Than [>] 50%) During 12-Month Follow-up | At 12 months follow-up post-procedure | 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%. |
| Rupture Rate of Target Aneurysm During 12-Month Follow-Up Post-Procedure | At 12 months follow-up post-procedure | The incidence of rupture of the target aneurysm within 12 months post-procedure will be reported. |
Countries
China
Contacts
CONTACTYuanyuan Gu
STUDY_DIRECTORJohnson & Johnson Medical (Shanghai) Ltd. Clinical Trial
Johnson & Johnson Medical (Shanghai) Ltd.
Outcome results
None listed