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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-jRCT1032240363
Enrollment
30
Registered
2024-10-03
Start date
2023-12-01
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

Ooishi Hidenori
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients who have undergone endovascular treatment using a neuroguidewire for ischemic stroke or cerebral aneurysm from January 1, 2022 to the date of Ethics Committee approval. 2) Patients who have given consent for the use of their medical information.

Exclusion criteria

Exclusion criteria: 1) Patients who used medical devices not approved in Japan 2) Patients under 18 years of age and those who need to obtain consent from a substitute 3) Patients whom the principal investigator considers to be unjustified as research subjects.

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 ContactHidenori Ooishi

Juntendo University School of Medicine Juntendo Clinic

investigationclinical.001@gmail.com+81-459112011

Outcome results

None listed

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