Acute Ischemic Stroke
Conditions
Interventions
Experimental group:ErussTM thrombectomy system
Sponsors
Jinling Hospital, Medical School of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. National Institutes of Health Stroke Scale (NIHSS)>=6; 3. Occlusion of the intracranial large vessel proven by CT angiography or MR angiography or digital subtraction angiography(large vessel defined as diameter>=2mm); 4. Subject is able to complete arterial puncture within 8 hours of onset of stroke symptoms; 5. Prestroke Modified Rankin Score <2; 6. Patient or patient's legally authorized representative can understand the purpose of the experiment and willing to signe and date an Informed Consent Form, Subject is willing to conduct protocol required follow up visits.
Exclusion criteria
Exclusion criteria: 1. Subject who has active hemorrhage or hemorrhagic tendency; 2. Uncontrollable by medication and sustained hypertension (SBP>=185mmHg or DBP>=110mmHg); 3. platelet count 22.2mmol/L; 5. Subject who has severe organic diseaseslike heart, lung, liver and kidney failure; 6. Allergies to contrast agents, nickel-titanium metals or their alloys; 7. Life expectancy of less than 90 days; 8. Woman of childbearing potential who is known to be pregnant or lactating or who has a pregnancy plan within 90 day; 9. Subject participating in other study involving an investigational drug or device; 10. Other circumstances that the researcher judges are not suitable for inclusion. Imaging Exclusion Criteria: 1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage or Massive cerebral infarction (Imaging test showing hyperintensity involving greater than 1/3 of the middle cerebral artery or >=70mL); 2. Occlusion of the intracranial large vessel reason is arterial dissection or arteritis; 3. Digital subtraction angiography showing access vessel tortuosity device is hard to reach target vessel or hard to recovery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful vessel recanalization rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of Successful vessel recanalization;Glasgow Score and National Institutes of Health Stroke Scale Score;Functional Independence as Defined by Modified Rankin Scale Score =2 at 90 Days;Success rate of device;Success rate of operation;Incidence rate of Symptomatic Intracerebral Hemorrhage in 24h post procedure;Incidence rate of adverse event and Serious adverse event;Incidence rate of Device defect;Mortality at 90 days; | — |
Countries
China
Contacts
Public ContactXinfeng Liu
Jinling Hospital, Medical School of Nanjing University
Outcome results
None listed