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To confirm efficacy and safety of VERSI system for acute ischemic stroke
Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thrombectomy | Experimental | thrombectomy by Versi system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thrombectomy | Device | mechanical thrombectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of treatment-related severe adverse event | symptomatic intracranial hemorrhage | within 24 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| recovery to independent life {modified Rankin score of 2 or less] | Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less | 90days after procedure |
| all intracralnial hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nobuyuki Sakai, MD DMSc | Kobe City Medical Center General Hospital, Kobe, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe City General Hospital | Kobe | Hyōgo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30262657 | Derived | Sakai N, Imamura H, Adachi H, Tani S, Tokunaga S, Funatsu T, Suzuki K, Adachi H, Sasaki N, Kawabata S, Akiyama R, Horiuchi K, Ohara N, Kono T, Fujiwara S, Kaneko N, Tateshima S. First-in-man experience of the Versi Retriever in acute ischemic stroke. J Neurointerv Surg. 2019 Mar;11(3):296-299. doi: 10.1136/neurintsurg-2018-014040. Epub 2018 Sep 27. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D017131 | Thrombectomy |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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incidence of symptomatic and asymptomatic intracranial hemorrhage
| within 24 hours after procedure |
| acceptable clinical outcome | Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less or back to baseline of mRS | 90days after procedure |
| Severe adverse event related to device | Any severe adverse event related to device | within 24 hours after procedure |
| recanalization ability of device | rate of immediate reperfusion with the device upto 3 path measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2b or greater | immediatry after procedure |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |