Clinical trial NCT04129203: Versi Retriever Approving Trial in Japan
Official title: Multi Center, Prospective, Registry Trial of Versi Retriever Mechanical Thrombecomy for Acute Ischemic Stroke in Japan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Keywords: acute ischemic stroke
Lead sponsor: Kobe City General Hospital
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Good clinical outcome
timeFrame: 90days after procedure
Secondary outcomes:
measure: Successful recanalization
timeFrame: at 3 passes of device in the procedure
measure: Successful recanalization
timeFrame: at end of procedure
measure: Symptomatic and asymptomatic intracranial hemorrhage
timeFrame: at 24 hours after procedure
measure: Good clinical outcome 2
timeFrame: 90days after procedure
measure: sever advers event
timeFrame: 90days after procedure
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
Study officials:
affiliation: Kobe City Medical Center General Hospital
name: Nobuyuki Sakai, MD DMSc
role: STUDY_CHAIR
References: