Recruiting
Not applicable
Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion
Condition(s) studied
StrokeCerebrovascular DisordersBrain DiseasesNervous System DiseasesVascular DiseasesIschemic StrokeInfarctionMedium Vessel Occlusion
Investigational drug(s) / intervention(s)
Intra-arterial ThrombolysisBest Medical Treatment
Intra-arterial Thrombolysis: rhTNK-tPA(Tenecteplase)dose: 0.4 - 1.2mg/min, maximum dose: 16mg. Patients who have not received IVT are recommended to initiate intra-arterial administration at a rate of 0.8 mg/min, whereas those who have received IVT are recommended to receive 0.4 mg/min. The infusion rate may be dynamically adjusted by the operator according to intra-procedural circumstances, with a maximum rate not exceeding 1.2 mg/min.
Best Medical Treatment: Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.
Study summary
Acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) or severe stenosis poses a significant clinical challenge. Recent large randomized controlled trials, DISTAL and ESCAPE-MeVO, demonstrated no significant benefit of endovascular therapy in patients with MeVO. Although intra-arterial thrombolysis has shown promise in clinical experience, robust evidence supporting its efficacy in MeVO or severe stenosis-related AIS is still absent. To fill this gap, the RESCUE MeVO trial has been designed as a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with AIS caused by MeVO or severe stenosis.
Eligibility
Inclusion Criteria:
* Age \> 18 years
* Primary medium vessel occlusion (MeVO) or severe stenosis (≥70%) 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:
1. 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, with no obvious hypodensity on CT and good collateral circulation on CTA;
2. 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 Criteria:
* Pre-stroke mRS ≥ 2
* Secondary MeVO or severe stenosis 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
Primary outcome measure(s)
- Excellent outcome — Time Frame: 90 ± 7 days
Number of participants achieving an excellent outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days follow-up. The mRS is a widely used 7-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Trial sites (6)
| Facility | City | Region | Status |
| Fu Yang People's Hospital |
Fuyang |
Anhui |
Recruiting |
| Lin Quan People's Hospital |
Fuyang |
Anhui |
Recruiting |
| The Second (Affiliated) Hospital of Anhui Medical University |
Hefei |
Anhui |
Recruiting |
| Shucheng People's Hospital |
Lu'an |
Anhui |
Recruiting |
| LiuZhou Worker's Hospital |
Liuzhou |
Guangxi |
Recruiting |
| Lishui Central Hospital |
Lishui |
Zhejiang |
Recruiting |
More The Second Hospital of Anhui Medical University trials in China
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