Ischemic Stroke
Conditions
Interventions
Intervention group:Angioplasty/stenting after mechanical thrombectomy
Control group:Only mechanical thrombectomy
Sponsors
The Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 or over 2. Acute ischemic stroke attributed to large artery occlusion, which is confirmed by CTA, MRA or DSA 3. CT or MRI scan ruling out intracranial hemorrhage 4. With onset time no more than 6 hours, or meeting the inclusion criteria of DEFUSE-III or DAWN trial 5. No disability before the onset of the disease (mRS score = 1 point) 6. Preoperative NIHSS score = 3 points 7. After successful thrombectomy (mTICI=2b), residual intracranial artery stenosis (=50%, including internal carotid artery [C5-C7], anterior [A1] or middle [M1] cerebral artery, vertebral artery [V3-V4] or basilar artery) confirmed by by angiography 8. Informed consent signed
Exclusion criteria
Exclusion criteria: 1. Any known non-atherosclerotic intracranial arterial stenosis, including but not limited to moyamoya disease, vasculitis, viral vasculopathy, neurosyphilis, intracranial infection, radiation vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, reversible vasoconstriction syndrome, postpartum vascular disease, vasospasm; if combined with intracranial arterial dissection, the enrollment of this case will be determined by interventional doctors 2. Women who plan to become pregnant, are pregnant or breastfeeding 3. Patients who cannot receive endovascular treatment, such as allergies to contrast media, allergies to nickel-titanium or other stent materials, with unstable vital signs, severe heart, liver and kidney insufficiency (GFR 185mmHg, or diastolic blood pressure > 110mmHg) 6. Active bleeding in non-compressible regions or known obvious bleeding tendency (such as hereditary or acquired bleeding factors, or lack of coagulation factors) 7. Blood glucose 22.2mmol/L 8. Life expectancy less than 90 days 9. Intracranial hemorrhage within 90 days before enrollment, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage (clinical diagnosis, even if no hemorrhage seen in the initial head CT or MRI), subdural hemorrhage or epidural hemorrhage 10. Suspected aortic dissection 11. Recent strong stress factors, such as severe burns, major surgery, acute myocardial infarction, septic shock 12. Previous neurological or psychiatric diseases which would affect neurological function scores or prognosis scores 13. Vascular torsion, calcification, previous stents, or stenosis that will prevent the passage or release of thrombectomy or stent devices 14. Huge mass or intracranial tumors (small meningiomas can be included), huge intracranial aneurysms or arteriovenous malformations 15. Ipsilateral extracranial artery stenosis (=70%) that cannot be treated simultaneously 16. Using illegal drugs or alcohol dependence (drinking more than 4 cups per day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day mRS;90-day stroke-related death;Barthel index; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90-day mRS 0-1;90-day mRS 0-2;90-day mRS 0-3;90-day mRS 0-4;90-day mRS 0-5;NIH stroke scale;Proportion of subjects with “early response”;Ischemic stroke recurrence;new TIA;recurrence of lethal stroke;recurrence of non-lethal stroke;symptomatic intracranial hemorrhage;neurological deterioration;All-cause mortality;Serious adverse events related to procedure or devices;infarct volume;infarct volume;Revascularization;successful stenting; | — |
Countries
China
Contacts
Public ContactJiang, Yongjun
The Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed