Post-marketing observational study on the efficacy and safety of Neuroguidewire and Guide Catheter NV2 for the treatment of AVM embolization

JRCT ID: jRCT1052230050

Registered date:24/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cerebral arteriovenous malformations (brain AVM)
• Date of first enrollment: 24/06/2023
• Target sample size: 30
• Countries of recruitment: Germany,Japan
• Study type: Observational

Outcome(s)

Primary Outcome

The rate of successful delivery of the micro catheter to the targeted locaton in the neurovasculature (Y/N).
Definition of successful delivery; The microcatheter tip should be located in an anatomically desirable location int the vessel to be treated.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

1.Patients who have undergone endovascular treatment for cerebral arteriovenous malformations using CHIKAI guidewires or FUBUKI guiding catheters 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: Kugai Miyahito
• Source(s) of Monetary Support: Asahi Intecc Co., Ltd.