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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial arm | Experimental | Mechanical thrombectomy using Versi Retriever |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Versi Retriever thrombectomy | Device | Mechanical thrombectomy using Versi Retriever |
|
| Measure | Description | Time Frame |
|---|---|---|
| Good clinical outcome | modified Rankin Score is 0-2 | 90days after procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nobuyuki Sakai, MD DMSc | Contact | 81783024321 | 080 | n.sakai@siren.ocn.ne.jp |
| Chiaki Sakai, MD PhD | Contact | 81783024321 | chiakimk@cronos.ocn.ne.jp |
| Name | Affiliation | Role |
|---|---|---|
| Nobuyuki Sakai, MD DMSc | Kobe City Medical Center General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe City Medical Center General Hospital | Recruiting | Kobe | Hyōgo | 650-0047 | Japan |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |