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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1032240364
Enrollment
30
Registered
2024-10-03
Start date
2023-10-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke and brain aneurysm Ischemic Stroke, AIS, stroke, Intracranial Aneurysm

Interventions

None listed

Sponsors

Takeuchi Masataka
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients treated with unapproved medical devices.

Design outcomes

Primary

MeasureTime frame
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?

Secondary

MeasureTime frame
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.

Contacts

Public ContactMasataka Takeuchi

SEISHO hospital

investigationclinical001@gmail.com+81-465-35-5773

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026