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

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

30

This is a retrospective study involving 30 patients who received treatment at Seisho Hospital. The median age of the patients was 76 years (ranging from 40 to 93), with 17 males and 13 females. There were 18 cases of ischemic stroke (9 MCA, 6 ICA, 3 BA) and 12 cases of cerebral aneurysms (10 ICA, 1 VA, 1 MCA).

This study was initiated after obtaining approval from the Ethics Committee of Seisho Hospital on September 22, 2023, and data collection was completed on October 5, 2023. The treatment dates for the patients were between June 23, 2023, and August 29, 2023, conducted as part of routine clinical practice.

In all 34 patients (34 cases), no device-related adverse events or malfunctions occurred.

The primary endpoint was the placement rate of the microcatheter at the intracranial treatment site, which was100% (30/30). The secondary endpoints included the guidewire's arrival rate at the target site, which was 100% (30/30), the necessity of switching devices, which was 0% (0/30), device-related adverse events, which were 0% (0/30), and device malfunctions, which were 0% (0/30).

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 76.0 years. There were 18 cases of AIS and 12 cases of IA. As a result, the placement rate of the microcatheter at the intracranial treatment site, which was 100% (30/30). 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/jRCT1032240364

Takeuchi Masataka

SEISHO hospital

1-16-35 Ogicho, Odawara-shi, Kanagawa

investigationclinical001@gmail.com

Takeuchi Masataka

SEISHO hospital

1-16-35 Ogicho, Odawara-shi, Kanagawa

+81-465-35-5773

investigationclinical001@gmail.com

Complete

Oct. 05, 2023

Observational

single arm study

open(masking not used)

uncontrolled control

single assignment

1) Patients who have undergone endovascular treatment using a CHIKAI neuroguidewire for stroke or aneurysm during the investigations period.

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 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?

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.

+81-465-35-5773

Sept. 15, 2023

none