progressing ischemic stroke with large arterial stenosis
Conditions
Interventions
Test group:urgent endovascular treatment + best medical treatment
Sponsors
the Second Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults (Age >=18 years old); 2. Clinical diagnosis is acute ischemic stroke, and imaging confirmed large artery stenosis (including C1-C7 segment of internal carotid artery, stenosis of M1 or proximal M2 vessel of middle cerebral artery, V1-V4 segment of vertebral artery, basilar artery stenosis); 3. Progress of symptoms, with recurrence of cerebral infarction in the same basin, or decreased flow perfusion; NIHSS score increased 2 points from the first NIHSS score, and the time of progression was more than 6 hours, less than 14 days; 4. The time of symptoms progressed to randomization <= 24 hours; 5. Thromthrombolytic therapy or intensive antiplatelet therapy within 6 hours of stroke onset following the relevant guidelines; 6. Pre-onset mRS score was 0-1; 7. Sign the informed consent form (or signed by the legal agent).
Exclusion criteria
Exclusion criteria: 1. Imaging confirmed the progressive symptoms caused by intracranial hemorrhage, cerebral edema, epileptic seizures and other definite causes; 2. A (chronic) large vessel occlusion in the known or suspected symptomatic area; 3. Balloon catheter cannot be used due to tortuous blood vessels; 4. Stent was implanted in the symptomatic area to hinder the use or removal of the surgical device; 5. Any other situation affecting the performance of the operation; 6. The presence of stenosis or occlusion of multiple vascular areas confirmed by CTA/MRA; 7. Pregnant subjects; 8. There is active bleeding, coagulopathy, or irreparable bleeding tendency: the platelet count is less than 40×10^9/L, and the international standardized ratio (INR) of anticoagulant therapy is greater than 2 (irreversible); 9. Severe cardiac, hepatic, and renal function impairment or other severe advanced systemic diseases; 10. subjects with contrast agent allergy; 11. Subjects who refuse to cooperate or cannot tolerate interventional surgery; 12. subjects with an expected survival period of <90 days; 13. Subjects that the investigator considers unable to participate in the follow-up visit; 14. Other investigator deemed unsuitable for balloon catheter or stent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| favorable outcome mRS0-2; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS shift analysis;EQ-5D-5L score;The infarct-core volume;Stroke severity;Stroke severity;The results of reperfusion;mortality; | — |
Countries
China
Contacts
Public ContactHao Wang
the Second Affiliated Hospital of Bengbu Medical University
Outcome results
None listed