Versi Retriever Approving Trial in Japan

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: Versi Retriever thrombectomy

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 Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nobuyuki Sakai, MD DMSc; Phone Number: 080 81783024321; Email: n.sakai@siren.ocn.ne.jp
• Study Contact Backup: Name: Chiaki Sakai, MD PhD; Phone Number: 81783024321; Email: chiakimk@cronos.ocn.ne.jp

Study Locations

• Japan
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
      • Recruiting
      • Kobe City Medical Center General Hospital
      • Contact: Chiaki Sakai, MD PhD; Phone Number: 81783024321; Email: chiakimk@cronos.ocn.ne.jp
      • Contact: Nobuyuki Sakai, MD, DMSc; Phone Number: 080 81783024321; Email: n.sakai@siren.ocn.ne.jp
      • Principal Investigator: Yasushi Matsumoto, MD
      • Principal Investigator: Yuji Matsumaru, MD
      • Principal Investigator: Shinichi Yoshimura, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trial arm; Mechanical thrombectomy using Versi Retriever	Device: Versi Retriever thrombectomy; Mechanical thrombectomy using Versi Retriever

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Good clinical outcome	modified Rankin Score is 0-2	90days after procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kobe City General Hospital
• Investigators: Study Chair: Nobuyuki Sakai, MD DMSc, Kobe City Medical Center General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: acute ischemic stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: VS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No