Stroke, Acute
Conditions
Keywords
acute ischemic stroke
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.
Interventions
DEVICEVersi Retriever thrombectomy
Mechanical thrombectomy using Versi Retriever
Sponsors
Kobe City General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Good clinical outcome | 90days after procedure | modified Rankin Score is 0-2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful recanalization | at 3 passes of device in the procedure | TICI 2b-3 |
| Symptomatic and asymptomatic intracranial hemorrhage | at 24 hours after procedure | NIHSS 4 or more worsened |
| Good clinical outcome 2 | 90days after procedure | mRS 0-2 or NIHSS 10 or more improvement |
| sever advers event | 90days after procedure | device or procedure related |
Countries
Japan
Contacts
Primary ContactNobuyuki Sakai, MD DMSc
Backup ContactChiaki Sakai, MD PhD
Outcome results
None listed