Versi Retriever Approving Trial in Japan

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04129203
• Other study ID #: VS-01
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: Kobe City General Hospital
• Contact: Nobuyuki Sakai, MD DMSc
• Phone: 81783024321
• Email: n.sakai[@]siren.ocn.ne.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• Versi Retriever thrombectomy
Mechanical thrombectomy using Versi Retriever

Locations

Country	Name	City	State
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Kobe City General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Good clinical outcome	modified Rankin Score is 0-2	90days after procedure
Secondary	Successful recanalization	TICI 2b-3	at 3 passes of device in the procedure
Secondary	Successful recanalization	TICI 2b-3	at end of procedure
Secondary	Symptomatic and asymptomatic intracranial hemorrhage	NIHSS 4 or more worsened	at 24 hours after procedure
Secondary	Good clinical outcome 2	mRS 0-2 or NIHSS 10 or more improvement	90days after procedure
Secondary	sever advers event	device or procedure related	90days after procedure