Acute large vessel occlusion
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=18 years. 2. Ischemic stroke confirmed by head CT or MRI. 3. Large vessel occlusion confirmed by CTA or MRA, including: intracranial internal carotid artery (ICA: cavernous + petrous segments, supraclinoid segment), middle cerebral artery (MCA M1). 4. Angiography shows severe stenosis (>=70%) in the responsible artery after recanalization therapy; or post-thrombectomy stenosis >50% with impaired flow and hypoperfusion; or failure to achieve >=2b reperfusion after three thrombectomy attempts, but achieving >=2b reperfusion after balloon dilatation (=6. 8. Baseline NIHSS >=6. 9. Target vessel deemed suitable for angioplasty by the operator. 10. Post-thrombectomy DSA confirmation of mTICI 2b/3 reperfusion in the occluded vessel. 11. Signed informed consent by the patient/legal authorized representative.
Exclusion criteria
Exclusion criteria: 1. Baseline systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg. 2. Baseline blood glucose 22.2 mmol/L. 3. Evidence of intracranial hemorrhage on pre-mechanical thrombectomy CT or MRI. 4. Confirmed or suspected cerebral vasculitis/fibromuscular dysplasia/dissection. 5. Operator judges that the interventional devices used in the study cannot reach the target site. 6. Stent placement in the middle cerebral artery during the thrombectomy procedure. 7. Requirement for >2 local balloon dilatations for angioplasty. 8. Contraindications to head MRI. 9. Occluded vessel combined with tandem extracranial stenosis or occlusion. 10. Number of thrombectomy attempts >3. 11. Space-occupying effect or intracranial tumor confirmed by CT or MRI. 12. Any signs of intracranial vessel perforation during mechanical thrombectomy. 13. Contraindications to antiplatelet therapy. 14. History of contraindications to contrast agents. 15. Current effective use of oral anticoagulants (e.g., warfarin with INR >1.7). 16. Pregnant or lactating women. 17. Known dementia or psychiatric illness preventing completion of neurological assessment and follow-up. 18. Life expectancy <3 months. 19. Participation in any other drug or medical device clinical trial, or potential participation within 3 months after enrollment in this trial. 20. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour mortality rate;Symptomatic Intracranial Hemorrhage;Vessel Reocclusion;Early Neurological Deterioration; | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D-5L;mRS score(analyzed an ordinal variable); | — |
Countries
China
Contacts
Tianjin Huanhu Hospital