Acute Ischemic Stroke
Conditions
Brief summary
To confirm efficacy and safety of VERSI system for acute ischemic stroke
Detailed description
Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure
Interventions
DEVICEthrombectomy
mechanical thrombectomy
Sponsors
Kobe City General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* onset to treat within 8 hours * NIHSS 8 or more * ASPECTS 5 or more * Target vessel is ICA, MCA, VA, BA, PCA * non-eligible or failed IV rt-PA
Exclusion criteria
* known hemorrhagic tendency * arterial dissection, vasculitis * allergy for contrast media * other inappropriate condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of treatment-related severe adverse event | within 24 hours after procedure | symptomatic intracranial hemorrhage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recovery to independent life {modified Rankin score of 2 or less] | 90days after procedure | Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less |
| all intracralnial hemorrhage | within 24 hours after procedure | incidence of symptomatic and asymptomatic intracranial hemorrhage |
| acceptable clinical outcome | 90days after procedure | Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less or back to baseline of mRS |
| Severe adverse event related to device | within 24 hours after procedure | Any severe adverse event related to device |
| recanalization ability of device | immediatry after procedure | rate of immediate reperfusion with the device upto 3 path measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2b or greater |
Countries
Japan
Outcome results
None listed