acute ischemic stroke
Conditions
Interventions
experimental group:BADDASS technology (Balloon guidance+large lumen distal pathway catheter+double suction+stent thrombectomy)
control group:SWIM technology (Suction catheter+bracket for bolt removal)
Sponsors
Renji Hospital Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age from 18 to 80 years old 2. Acute ischemic stroke with anterior circulation confirmed by preoperative imaging (CTA/DSA/MRA) (occlusion of M1 or M2 segment of internal carotid artery or middle cerebral artery, with M2 segment as determined by the physician) 3. NIHSS=6 and pre-onset mRS=2 4. Thrombectomy can be performed directly if the time from onset to puncture completion is less than 6 hours; If the time from symptom onset to puncture completion was > 6 hours and =24 hours, head CT or MRI should be performed, and ASPECTS =6 points, or CTP or MRP should be performed to evaluate the infarct core and ischemic penumbra 5. Patients or guardians can provide written informed consent for follow-up
Exclusion criteria
Exclusion criteria: 1. Large area cerebral infarction in the anterior circulation (infarct volume =70ml or infarct area > 1/3MCA territory) or lesion mass effect leading to midline structure shift in the early stage confirmed by imaging examination 2. Intracranial hemorrhage or subarachnoid hemorrhage confirmed by imaging examination (microbleeds on SWI are not included, or the surgeon's judgment is based on clinical experience) 3. Angiography showed occlusion of the intracranial artery due to arteritis, myofibrodysplasia, and moyamoya disease 4. Access tortuosity or other difficulties prevent the test device from reaching the target vessel 5. Known allergy/resistance or contraindication to one or more of the following: antiplatelet/anticoagulant/contrast and/or anesthetic agents 6. Known allergies to devices and related products involved in the trial medical technology (allergies to materials such as nickel-titanium metal or its alloys) 7. Active bleeding or known bleeding tendency (e.g., patients receiving preoperative anticoagulant therapy or coagulopathy, INR > 3.0, except patients receiving preoperative thrombolysis) 8. Platelet count less than 40×10^9/L 9. Combined intracranial tumors, aneurysms, or intracranial arteriovenous malformations 10. Patients with known severe cardiac, hepatic, or renal failure (e.g., serum creatinine >2.5 mg/dL or >221 umol/L) or dialysis 11. Myocardial infarction with ST-segment elevation or severe infection (endocarditis or sepsis) 12. Medically uncontrolled hypertension (sustained systolic blood pressure =185 mmHg or sustained diastolic blood pressure =110mmHg) 13. After treatment, blood glucose concentration 22.2 mmol/L 14. Pregnant women or women planning to become pregnant in the next 6 months (by taking medical history) 15. Inability to complete a neurological assessment with known dementia or psychiatric illness 16. Patients who are participating in clinical studies of other drugs or devices 17. Patients who were deemed by the investigator to be ineligible for the study for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful recanalization rate of target vessel; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-care rate 7 days after surgery or before discharge and 90 days after discharge (proportion of mRS 0-2);Rate of satisfactory reperfusion of the target vessel after the first thrombectomy (proportion of eTICI 2b-3);Level 3 Success rate;The success rate was 3 grades at one time;Satisfactory reperfusion time of target vessels;Proportion on rescue therapy;Changes in NIHSS;All-cause and stroke-related mortality within 90 days;Recurrent stroke within 90 days;Postoperative symptomatic intracranial hemorrhage and intracranial hemorrhage of any type;Procedure-related complications;Adverse events ; | — |
Countries
China
Contacts
Public ContactShenghao Ding associate professor
Renji Hospital Shanghai Jiaotong University School of Medicine
Outcome results
None listed