Acute Ischemic Stroke
Conditions
Interventions
Experiment group:Proximal flow control device (balloon guiding catheter) plus endovascular treatment group (experimental group)
Control group:Conventional access catheter plus endovascular treatment group (control group)
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old; 2. Patients who received endovascular treatment for acute large vessel occlusive stroke within 24 hours of onset; 3. Anterior circulation large vessel occlusive stroke (ICA, M1, M2) judged by clinical symptoms or imaging examination; 4. NIHSS score> 5 points; 5. ASPECTS score>=3; 6. Patients or family members sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhage confirmed by CT or MRI of the head; 2. Severe stenosis (>90%) or tandem occlusion of the lateral cranial segment of the ipsilateral internal carotid artery; 3. Stent previously implanted in the ipsilateral carotid artery; 4. Dissection of the ipsilateral carotid artery; 5. Participating in other drug or device clinical trials affecting this study; 6. Pre-onset mRS score >=2 points; 7. Pregnant or lactating women; 8. Allergy to contrast agents; 9. Blood glucose 22.2mmol/L (400mg/dl); 10. Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg, and oral antihypertensive drugs cannot be controlled; 11. Genetic or acquired bleeding constitution, lack of anticoagulant factors; or have taken oral anticoagulants with INR>1.7; 12. Platelet count less than 70x 10^9/L; 13. Arterial tortuosity causes thrombectomy device to fail to reach the target blood vessel; 14. History of bleeding (gastrointestinal and urinary tract bleeding) in the past 1 month; 15. Patients with chronic hemodialysis and severe renal insufficiency (glomerular filtration rate 220µmol/L (2.5mg/dl)); 16. Life expectancy < 6 months due to advanced disease; 17. Expected to be unable to complete follow-up; 18. Intracranial aneurysm, arteriovenous malformation; 19. Brain tumors with mass effect on imaging; 20. Macular edema;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The distribution of mRS score at 90d;Mortality at 90d(%);Symptomatic intracranial hemorrhage (sICH) (defined based on the Heidelberg hemorrhage grading); | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS score 0-1 at 90d(%);mRS score 0-2 at 90d(%);mRS score 0-3 at 90d(%);mRS score 0-4 at 90d(%);Changes in NIHSS score 5-7 days ;Successful recanalization proportion after the first thrombectomy (eTICI 2b50-3);Perfect recanalization proportion after the first thrombectomy (eTICI 2c-3);Complete recanalization proportion after the first thrombectomy (eTICI 3);Successful recanalization rate at the end of the procedure (eTICI 2b50-3);Complete recanalization rate post-procedure (eTICI 2c-3);Time from puncture to recanalization;90-day EQ-5D scale score; | — |
Countries
China
Contacts
Public ContactZheng Peng
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed