A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms

NCT07228312 | Recruiting

• 1 other identifier: CNV202507
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (9)

• 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 (%).

  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 %.

  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 %.

  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.

  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.

  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.

  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.

  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%.

  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.

  At 12 months follow-up post-procedure

Study Arms (1)

Choydar Flow-Directed Mesh Stent

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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. The aneurysm must have a neck width greater than or equal to (\>=) 4 millimeters (mm) or a dome-to-neck ratio less than (\<) 2, and the parent artery diameter must be \>= 2.0 mm and less than or equal to (\<=) 6.0 mm, including saccular and fusiform aneurysms
• 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
• \- 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. The aneurysm must have a neck width \>= 4 mm or a dome-to-neck ratio \< 2, and the parent artery diameter must be \>= 2.0 mm and \<= 6.0 mm, including saccular and fusiform aneurysms

You may not qualify if:

• Participants with anatomy are unsuitable for flow diverter passage or placement or lesions unsuitable for flow diverter delivery and deployment (for example, the lesion vessel is excessively tortuous or tiny, the flow diverter cannot reach the lesion site, stenosis exists in the target vessel of recurrent aneurysm, or the flow diverter is not completely deployed)
• Participants who are allergic to contrast media
• Participants who are allergic to nickel-titanium alloy or platinum-tungsten alloy
• Participants who are contraindicated for antiplatelet and/or anticoagulant therapy
• Participants with active bacterial infections
• Participants who are confirmed positive pregnancy (for example, via test or oral communication) according to the site-specific standard of care
• Participants who are currently participating in an investigational (drug, device, etc.) clinical study that may confound the study endpoints (excluding observational, natural history, and/or epidemiological studies that do not require interventions)

Sponsors & Collaborators

• Johnson & Johnson Medical (Shanghai) Ltd.: lead

Study Sites (3)

Guangdong Provincial People's Hospital

Guangzhou, 519041, China

RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, 210008, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial

  Johnson & Johnson Medical (Shanghai) Ltd.

  STUDY DIRECTOR

Central Study Contacts

Yuanyuan Gu

CONTACT

86 1592105615; ygu51@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): February 10, 2028
• Study Completion (Estimated): February 10, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)