WS-01 long-term observational study

Multicenter study evaluating safety and the performance of the intracranial stent system (WS-01) for the treatment of intracranial atherosclerotic disease - WS-01

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1090220035

Enrollment

20

Registered

2010-03-09

Start date

2010-03-10

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

patients, treated with WS-01 stent for recurrent stroke attributable to intracranial atherosclerotic disease, refractory to medical treatment, in intracranial vessels.

Interventions

Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use:

Sponsors

Kobe City Hospital Organization General Hospital Nobuyuki Sakai

Lead Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients treated with WS-01 stent for recurrent stroke attributable to intracranial atherosclerotic disease, refractory to medical treatment, in intracranial vessels patients

Exclusion criteria

Exclusion criteria: No

Design outcomes

Primary

Measure	Time frame
modified Rankin Scale at 2 yeras after WS-01 stent deployment	—

Secondary

Measure	Time frame
patency rate at 2 years after WS-01 stent deployment in-stent-restenosis rate at 2 years after WS-01 stent deployment retreatment rate at 2 years after WS-01 stent deployment adverse event rate at 2 years after WS-01 stent deployment	—

Countries

Japan

Contacts

Public ContactChiaki Sakai, Chun Hee Kim

Kobe City Hospital Organization General Hospital

chiakisa@fbri.org+81-78-302-4321

Outcome results

None listed

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