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

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

30

This study is a retrospective study of 30 patients treated at Yokohama Shintoshin Hospital. The median age of the patients was 72.5 years (range 21-78), with 9 males and 21 females. There were 6 cases of ischemic stroke (4 ICA, 1 MCA, 1 VA) and 24 cases of cerebral aneurysm (9 ACA, 9 ICA, 4 MCA, 2 VA).

This study was initiated after obtaining approval from the Ethics Committee of Yokohama Shintoshin Hospital on August 4, 2023, and data collection was completed on October 12, 2023. The treatment dates for the patients were between February 1, 2022, and November 24, 2022, and the data were collected during routine clinical practice.

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

The primary endpoint was a 90% (27/30) success rate of microcatheter placement in the cerebrovascular treatment site. Secondary endpoints included a 90% (27/30) success rate of guidewire (GW) reaching the target site, a 0% (0/30) need for exchange, 0% (0/30) device-related adverse events, and 0% (0/30) device malfunctions.

This is a retrospective study evaluating the efficacy and safety of the CHIKAI in 30 patients who underwent treatment for ischemic stroke and cerebral aneurysms using CHIKAI. The median age of the patients was 72.5 years. There were 6 cases of AIS and 24 cases of IA. As a result, the placement rate of the microcatheter at the intracranial treatment site, which was 90% (27/30). And device-related adverse events, which were 0% (0/30), and device malfunctions, which were 0% (0/30).

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1032240362

Morimoto Masafumi

Yokohamashintoshi Neurosurgical Hospital

443 Ebatachou, Aoba-ku, Yokohama-shi, Kanagawa, Japan

investigationclinical.001@gmail.com

Morimoto Masafumi

Yokohamashintoshi Neurosurgical Hospital

443 Ebatachou, Aoba-ku, Yokohama-shi, Kanagawa, Japan

+81-45-911-2011

investigationclinical.001@gmail.com

Complete

Sept. 23, 2023

Observational

single arm study

open(masking not used)

uncontrolled control

other

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.

1.Patients treated with unapproved medical devices.

acute ischemic stroke and brain aneurysm

Ischemic Stroke, AIS, stroke, Intracranial Aneurysm

Ischemic Stroke / Intracranial Aneurysm

Efficacy
Success rate of microcatheter guidance

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.

+81-459112011

Aug. 04, 2023

none