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A Multicenter, Prospective, Single-Arm Observational Study to Evaluate the Safety and Effectiveness of the Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
China
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Yuanyuan Gu
ygu51@its.jnj.com
86 15692105615
Time Frame
Start Date: 2026-01-28
Estimated Completion Date: 2028-02-10
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Johnson & Johnson Medical (Shanghai) Ltd.

This content was sourced from clinicaltrials.gov