Versi Retriever Approving Trial in Japan

Not Applicable

• Conditions: Stroke, Acute
• Interventions: Device: Versi Retriever thrombectomy

• Registration Number: NCT04129203
• Lead Sponsor: Kobe City General Hospital

Brief 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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-01
• Last Update Posted: 2020-11-03
• Primary Completion: 2021-03-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trial arm	Versi Retriever thrombectomy	Mechanical thrombectomy using Versi Retriever

Primary Outcome Measures

Name	Time	Method
Good clinical outcome	90days after procedure	modified Rankin Score is 0-2

Secondary Outcome Measures

Name	Time	Method
Successful recanalization	at end of procedure	TICI 2b-3
Good clinical outcome 2	90days after procedure	mRS 0-2 or NIHSS 10 or more improvement
Symptomatic and asymptomatic intracranial hemorrhage	at 24 hours after procedure	NIHSS 4 or more worsened
sever advers event	90days after procedure	device or procedure related

Trial Locations

Locations (1)

Kobe City Medical Center General Hospital; 🇯🇵 Kobe, Hyogo, Japan