Status:
RECRUITING
Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion
Lead Sponsor:
Tang-Du Hospital
Collaborating Sponsors:
The First people's hospital of Xian Yang
First People's Hospital Of Tianshui
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of IMPACT-LVO trial is to investigate the efficacy and safety of early adjunctive intra-arterial combined with intravenous administration methylprednisolone sodium succinate after successf...
Eligibility Criteria
Inclusion
- Age 18-80 years old; 2) The time from onset to randomization was within 24 hours; 3) Large vessel occlusive stroke in the anterior circulation confirmed by CTA/MRA/DSA (Including intracranial segment of internal carotid artery, M1 or M2 segment of middle cerebral artery) and the vessel responsible for the signs and symptoms of acute ischemic stroke; 4) NIHSS score \>= 6 points 5) Alberta Stroke Program Early Diagnosis (ASPECTS) score of NCCT \>=3; 6) Successful endovascular thrombectomy (eTICI 2b50-3) 7) Written informed consent signed by patients or their family members
Exclusion
- Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);
- Prestroke mRS score \>= 2
- pregnant or lactating patients
- Allergy to iodinated contrast media, or methylprednisolone sodium succinate
- Participating in other clinical research;
- Inherited/acquired hemorrhagic diathesis (coagulation factor deficiency) or oral anticoagulation with international normalized ratio (INR) \>1.7
- History of major bleeding within the past 1 month (gastrointestinal/genitourinary hemorrhage)
- Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30ml/min/1.73m\^2 or serum creatinine \> 220μmol/L (2.5mg/dl));
- Terminal illness with life expectancy \<6 months;
- Blood glucose \< 2.8mmol/L (50mg/dl) or \> 22.2mmol/L (400mg/dl);
- Intracranial aneurysm, arteriovenous malformation, or space-occupying brain tumor with mass effect on imaging
- Active systemic infectious disease
- Anticipated inability to complete follow-up
- Intraoperative DSA showed vascular perforation, dissection, and contrast extravasation;
- Puncture to recanalization was more than 90 minutes; Total thrombectomy passes \>3
Key Trial Info
Start Date :
August 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
1060 Patients enrolled
Trial Details
Trial ID
NCT07141303
Start Date
August 8 2025
End Date
June 30 2028
Last Update
September 18 2025
Active Locations (1)
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1
Tangdu Hospital
Xi'an, Shaanxi, China, 710038