Post-marketing observational study on the efficacy and safety of Neuroguidewire for the treatment of istroke and aneurysm

JRCT ID: jRCT1032240362

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: 23/09/2023
• Target sample size: 30
• Study type: Observational

Outcome(s)

Primary Outcome

Efficacy
Success rate of microcatheter guidance

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 cannot 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.
2) Patients who have given consent for the use of their medical information.

• Exclude criteria: 1.Patients treated with unapproved medical devices.

Related Information

• Primary Sponsor: Morimoto Masafumi