An observational study in Intracranial Aneurysm, sponsored by Johnson & Johnson Medical (Shanghai) Ltd.. Recruiting at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Johnson & Johnson Medical (Shanghai) Ltd. (part of Johnson & Johnson) · Observational
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.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Johnson & Johnson Medical (Shanghai) Ltd. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult participants with unruptured wide-neck (neck width >= 4 mm or dome-to-neck ratio \<2) saccular or fusiform aneurysms in the internal carotid artery (from the petrous segment to the distal end) and the vertebral artery arising from a parent vessel with a diameter >= 2.0 mm and \<= 6.0 mm.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants meeting all the following inclusion criteria will be included:
Preoperative inclusion criteria:
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 exclusion criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The choydar flow-directed mesh stent will be used in accordance to its Instructions For Use (IFU) in participants with unruptured intracranial aneurysms. Participants will not receive any other intervention as a part of this study.
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
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
Plan to share: Yes — The data sharing policy of Johnson \& Johnson MedTech is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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