NCT04129203

Versi Retriever Approving Trial in Japan

Multi Center, Prospective, Registry Trial of Versi Retriever Mechanical Thrombecomy for Acute Ischemic Stroke in Japan

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Kobe City General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	Versi Retriever thrombectomy	Mechanical thrombectomy using Versi Retriever

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-03-31
• Completion: 2021-12-31
• First posted: 2019-10-16
• Last updated: 2020-11-03

Locations

1 site across 1 country: Japan