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

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

31

Patients who consented to participate in the study on AVM embolization treatment using the Neuro Guidewire and Guide Catheter NV2 were retrospectively registered. The patients included 8 males and 4 females, with an average age of 34.8 years (ranging from 15 to 60). The study included 12 cases (31 data points of AVM embolization treatment) treated between March 1, 2022, and July 12, 2022. The medical history and complications included cerebral hemorrhage (3 cases), arrhythmia (1 case), and epilepsy (1 case).

The study was initiated after obtaining approval from the Ethics Committee of Tominaga Hospital on May 22, 2023. Data transcription began on July 28, 2023, and data collection for the case report forms was completed on September 1, 2023. The treatment dates for the patients were between March 1, 2022, and July 12, 2022, conducted as part of routine clinical practice. Additionally, on July 12, 2023, the study protocol was revised to extend the study period and add participating physicians, which required re-approval. The collected data was reported to Tominaga Hospital and, after waiting for the European data, was compiled into a final report in 2024.

No device-related adverse events or device malfunctions occurred in any of the 12 patients (30 cases).

The primary endpoint was defined as the successful placement of the microcatheter at the target intracranial vascular site. The success rate was 29 out of 31 cases (98%). The secondary endpoints were set as follows: Efficacy Reaching the target site with the guiding catheter: 12 out of 13 cases (92%) Reaching the target site with the guidewire: 31 out of 31 cases (100%) Guiding the microcatheter to the target site using the guidewire: 30 out of 31 cases (98%) Necessity of switching to another guidewire or guiding catheter: 1 out of 31 cases (2%) Microcatheters used in combination (product names): Marathon (24), DeFrictor (7) Safety Presence of any procedural issues related to the device: 0 out of 12 cases (0%) Presence of adverse events that cannot be ruled out as related to the device: 0 out of 12 cases (0%)

A retrospective study on AVM embolization treatment using the CHIKAI and FUBUKI was conducted at Single center. The study included 12 patients (31case, 8 males and 4 females) with an average age of 34.8 years (ranging from 15 to 60). As a result, the delivery rate of the microcatheter to the intracranial vessels was achieved in 29 out of 31 cases (98%), with no device-relate adverse events or malfunctions reported.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1052230050

Kugai Miyahito

Kotobuki Social Medical Corporation Tominaga Hospital

1-4-48 Minatomachi, Naniwa-ku, Osaka-shi, Osaka, Japan

investigationclinical.001@gmail.com

Kugai Miyahito

Kotobuki Social Medical Corporation Tominaga Hospital

1-4-48 Minatomachi, Naniwa-ku, Osaka-shi, Osaka, Japan

+81-6-6568-1601

investigationclinical.001@gmail.com

Complete

June. 24, 2023

Observational

single arm study

open(masking not used)

uncontrolled control

single assignment

other

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.

1. Patients treated with unapproved medical devices.

cerebral arteriovenous malformations (brain AVM)

brain AVM

Intracranial Arteriovenous Malformations, MeSH Unique ID: D002538

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.

+81-6-6568-1601

May. 22, 2023

Germany