Versi Retriever Approving Trial in Japan

Kobe City General Hospital

Status: Unknown

Conditions: Stroke, Acute

Treatments: Device: Versi Retriever thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04129203

VS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute onset neurological sympto m related to occluded vessel
• within 8 hours from onset to tre atment or within 24 hours from onset to treatment with imaging diagnosis
• contra-indication or failed to int ravenous rt-PA
• accessible occlusion at ICA, MC A, VA, BA, PCA
• 5-30 of NIHSS
• 0-2 of mRS before onset
• obtain documented informed co ntent

Exclusion criteria

• following condition; arterial diss ection, engird, inaccessible turtuousity, difficult access by 50% or m ore stenosis, acute intracranial hemorrhage, space occuping lesion or brain tumor, major early ischemic change in brain
• occlude 2 major vessel territory
• allege for contrast media,
• abnormal PTT/APTT within 4 h ours intravenous heparin
• hemorrhagic tendency or 3 or more INR with Warfarin administration
• 30000cc or less of Platelet
• 50mg/dL or less of blood sugar
• uncontrolled blood pressure, 185mmHg or more at systolic, 110m mHg or more at diastolic
• 90days or less life expancy
• pregnant or lactating
• join another trial of medicine or medical device
• ineligible for trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Trial arm

Experimental group

Description:

Mechanical thrombectomy using Versi Retriever

Treatment:

Device: Versi Retriever thrombectomy