Versi Retriever Approving Trial in Japan
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Stroke Acute
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 85 years
- Gender
- Both males and females
Description
This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital. 60 cases will be enrolled and 90 days follow up need. Primary endpoint is ...
This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital. 60 cases will be enrolled and 90 days follow up need. Primary endpoint is favorable clinical outcome, mRS 0-2. Secondary endpoint are mortality in 90days, immediate successful recanalization, TICI 2b-3, symptomatic intracranial hemorrhage, and any adverse event related to device and or procedure.
Tracking Information
- NCT #
- NCT04129203
- Collaborators
- Not Provided
- Investigators
- Study Chair: Nobuyuki Sakai, MD DMSc Kobe City Medical Center General Hospital
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