WS-01 long-term observational study

JRCT ID: jRCT1090220035

Registered date:09/03/2010

Basic Information

• Recruitment status: COMPLETED
• Health condition(s) or Problem(s) studied: patients, treated with WS-01 stent for recurrent stroke attributable to intracranial atherosclerotic disease, refractory to medical treatment, in intracranial vessels.
• Date of first enrollment: 10/03/2010
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Observational

Intervention(s)

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Outcome(s)

• Primary Outcome: modified Rankin Scale at 2 yeras after WS-01 stent deployment

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

• Exclude criteria: No

Related Information

Primary Sponsor

Kobe City Hospital Organization General Hospital
Nobuyuki Sakai

• Secondary Sponsor: none
• Source(s) of Monetary Support: Japan Ministry of Health Labour and Welfare
• Secondary ID(s): JMA-IIA00035