Post-marketing observational study on the efficacy and safety of NeuroGuideWire for the treatment of stroke and aneurysm

JRCT ID: jRCT1032240364

Registered date:03/10/2024

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: acute ischemic stroke and brain aneurysm
• Date of first enrollment: 05/10/2023
• Target sample size: 30
• Study type: Observational

Outcome(s)

Primary Outcome

Efficacy: success rate of microcatheter induction
Definition of successful induction: a successful induction is considered when any of the following (1) to (4) are met.
(1) Was the microcatheter tip able to reach the aneurysm?
(2) Was the microcatheter tip or the balloon portion of the balloon catheter able to reach the distal portion beyond the aneurysm?
(iii) Was the tip of the microcatheter able to reach just before the site of occlusion or stenosis?
(iv) Was the microcatheter tip able to reach the distal portion beyond the site of occlusion or stenosis?

Secondary Outcome

Efficacy
1) Reach of the research device (guidewire) to the target site
2) Need for replacement with other neuroguidewire
3) Microcatheter or balloon catheter used in combination (product name)

Safety
1) Failure during the procedure related to the research device.
2) Whether or not there are any adverse events that can not be ruled out as causally related to the research device.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Include criteria: 1) Patients who have undergone endovascular treatment using a CHIKAI neuroguidewire for stroke or aneurysm during the investigations period.
• Exclude criteria: Patients treated with unapproved medical devices.

Related Information

• Primary Sponsor: Takeuchi Masataka