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A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.
The OCIN-AIS-EVT REGISTRY is a prospective, multicenter, blinded outcome evaluation, observational trial, and aims to determine the functional outcomes and safety of endovascular treatment for AIS, due to vessel occlusion in anterior and posterior circulation, in routine clinical practice.
The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment | Device | Endovascular treatment, such as mechanical thrombectomy with stent, aspiration catheter or stent assisted by intermediate aspiration catheter, as well as combination of mechanical thrombectomy with intra-arterial thrombolysis |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome | Shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days). The value range 0-6: higher scores mean a worse outcome. | 90days |
| Measure | Description | Time Frame |
|---|---|---|
| Dichotomized modified Rankin scale (mRS) | Dichotomized modified Rankin scale (mRS) at 90 days after the procedure (0-1 versus 2-6, 0-2 versus 3-6, 0-3 versus 4-6). The value range 0-6: higher scores mean a worse outcome. | 90days |
| NIHSS at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Death | All-cause death | 7 days and 90 days |
| Intracerebral hemorrhage(ICH) | Intracranial hemorrhage, including symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage |
Inclusion Criteria:
Exclusion Criteria:
1) No exclusion criteria
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All acute ischemic stroke patients receiving endovascular treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengfei Yang, M.D. | Contact | 86-21-31161784 | 15921196312@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianimin Liu, M.D. | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianimin Liu | Recruiting | Shanghai | China |
Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
Data sharing will be available from 12 months after the publication of the main results.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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thrombus
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours post- procedure. The value range 0-42: higher scores mean a worse outcome.
| 24 hours post-procedure |
| NIHSS at 7 days | National Institutes of Health Stroke Scale (NIHSS) score at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome. | 7 days post procedure |
| Reperfusion outcome | Immediate target vessel recanalization rate post-procedure: defined as proportion of subjects with extended thrombolysis in cerebral infarction (eTICI) score is 2b to 3 The value range 0-3: higher scores mean a better outcome. | Immediately post-procedure |
| Early successful revascularization rate | Early successful revascularization rate of target vessels by bridging therapy | During procedure |
| Target vessel recanalization rate | Target vessel recanalization rate at 7 days post-procedure (assessed by CTA or MRA or DSA) | at 7 days post-procedure |
| 90 days |
| Procedure related complication | Procedure related complication | within 30 days after procedure |
| Device related complications | Device related complications | within 30 days after procedure |
| adverse events of special interest | Other adverse events of special interest | within 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |