Status:
NOT_YET_RECRUITING
Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion
Lead Sponsor:
The Second Hospital of Anhui Medical University
Conditions:
Stroke
Cerebrovascular Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) poses a significant clinical challenge. Recent large randomized controlled trials, DISTAL and ESCAPE-MeVO, demonstrated no significant...
Detailed Description
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial. Eligible participants will be adults (age \>18 years) presenting with acute ischemic stroke (AIS) due...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Primary medium vessel occlusion (MeVO) was detected on CTA, MRA, or DSA, involving arterial segments including M2-M3 of the middle cerebral artery (MCA), A1-A2 of the anterior cerebral artery (ACA), P1-P2 of the posterior cerebral artery (PCA), and the anterior inferior cerebellar artery (AICA), posterior inferior cerebellar artery (PICA), and superior cerebellar artery (SCA)
- The clinical symptoms were consistent with MeVO, with a NIHSS score 5 - 25, or an NIHSS score of 3-4 in the presence of disabling neurological deficits (e.g., hemianopia, aphasia, or motor dysfunction)
- Intra-arterial thrombolysis was administered within the following time windows:
- Acute ischemic stroke within 24 hours of symptom onset or last known well, including stroke with known onset, wake-up stroke and stroke with unknown onset;
- Acute ischemic stroke within 24-72 hours of onset, meeting at least one of the following imaging criteria: a.CT or MR perfusion imaging demonstrating target mismatch, defined as an ischemic core volume \<30 mL, a mismatch ratio ≥1.2, and a mismatch volume ≥10 mL.; b.MRI demonstrating DWI-FLAIR mismatch, defined as the presence of acute ischemic lesions on diffusion-weighted imaging (DWI) with no corresponding hyperintense signal on FLAIR, or with FLAIR hyperintense lesions occupying less than one-third of the DWI lesion volume.
- Signed informed consent obtained
Exclusion
- Pre-stroke mRS ≥ 2
- Secondary MeVO caused by endovascular therapy
- Neuroimaging demonstrated intracranial hemorrhage, subarachnoid hemorrhage, or other hemorrhagic disorders
- Non-contrast CT demonstrating a clearly hypodense lesion corresponding to the vascular territory
- Platelet count \<100 × 10⁹/L, known bleeding tendency or coagulation factor deficiency, or oral anticoagulant therapy with an international normalized ratio (INR) \>3.0
- Persistent and uncontrolled hypertension, defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg
- History of intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, or subdural hemorrhage
- Presence of arteriovenous malformations or brain tumors with mass effect
- Gastrointestinal or urinary tract bleeding, or major surgery within the past 3 months
- Chronic dialysis or severe renal impairment, defined as a glomerular filtration rate (GFR) \<30 mL/min or serum creatinine \>220 μmol/L (2.5 mg/dL)
- Patients with known allergy to thrombolytic agents or their excipients
- Patients with known allergy to iodinated contrast agents or other established contraindications
- Pregnant or current breastfeeding
- Presence of severe systemic comorbidities with a life expectancy of less than 3 months
- Deemed unsuitable for participation by the investigator for any reason
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT07185022
Start Date
October 1 2025
End Date
May 1 2030
Last Update
September 26 2025
Active Locations (1)
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1
The Second (Affiliated) Hospital of Anhui Medical University
Hefei, Anhui, China, 230031