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| Name | Class |
|---|---|
| Hunan Rui Kang Tong technology development co., LTD | UNKNOWN |
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This study is to test a hypothesis that temporary implantation of JRecanTM blood flow recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a major intracranial artery occlusion following IV r-tPA can provide a greater rate of early successful recanalisation than treatment of IV r-tPA alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV r-tPA with JRecanTM blood FR device | Experimental | Dual IV r-tPA therapy and adjunctive treatment with JRecanTM blood flow recanalisation device |
|
| IV r-tPA | Active Comparator | IV infusion of r-tPA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JRecanTM blood FR device | Device | JRecanTM blood flow recanalisation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early successful recanalisation (assessed by the imaging core laboratory) | TIMI(thrombolysis in myocardial infarction)2 or 3 recanalisation 1 hour after enrollment blindly assessed by the imaging core laboratory and without any presence of symptomatic intracranial hemorrhage within 24 hours blindly assessed by independent neurologists. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Good neurological outcome( modified Rankin Scale (mRS) score ≤2, or National Institutes of Health Stroke Scale(NIHSS)score improvement of 10 points or more) | modified Rankin Scale (mRS) score ≤2, or National Institutes of Health Stroke Scale(NIHSS)score improvement of 10 points or more. | 90 days |
| Incidence of device related and procedure-related serious adverse events(SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijian Jiang, MD,PhD | Contact | +8613901122837 | cjr.jiangweijian@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weijian Jiang, MD,PhD | New Era Stroke Care and Research Institute, The Second Artillery General Hospital Beijing | Principal Investigator |
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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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| IV r-tPA | Drug | intravenous recombinant human tissue plasminogen activator |
|
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The incidence of device related and procedure-related serious adverse events(SAEs) |
| 30 days |
| Additional safety end-points (symptomatic intracranial haemorrhage at 24 hours, and Death due to any cause at 90 days) | symptomatic intracranial haemorrhage at 24 hours, and Death due to any cause at 90 days | 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |