Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy, Thrombosis
Conditions
Brief summary
A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.
Detailed description
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).
Interventions
DEVICEEndovascular treatment
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
Sponsors
Changhai Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Acute ischemic stroke caused by anterior or posterior circulation vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA) 2. Undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture) 3. The patient or his/her legal representative agreed to participate in the study and has signed the informed consent.
Exclusion criteria
1\) No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome | 90days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIHSS at 24 hours | 24 hours post-procedure | National Institutes of Health Stroke Scale (NIHSS) score at 24 hours post- procedure. The value range 0-42: higher scores mean a worse outcome. |
| Dichotomized modified Rankin scale (mRS) | 90days | 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. |
| NIHSS at 7 days | 7 days post procedure | National Institutes of Health Stroke Scale (NIHSS) score at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome. |
| Reperfusion outcome | Immediately post-procedure | 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. |
| Early successful revascularization rate | During procedure | Early successful revascularization rate of target vessels by bridging therapy |
| Target vessel recanalization rate | at 7 days post-procedure | Target vessel recanalization rate at 7 days post-procedure (assessed by CTA or MRA or DSA) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedure related complication | within 30 days after procedure | Procedure related complication |
| Device related complications | within 30 days after procedure | Device related complications |
| adverse events of special interest | within 90 days | Other adverse events of special interest |
| Intracerebral hemorrhage(ICH) | 90 days | Intracranial hemorrhage, including symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage |
| Death | 7 days and 90 days | All-cause death |
Countries
China
Contacts
Primary ContactPengfei Yang, M.D.
Outcome results
None listed