Intra-arterial clot-dissolving treatment for medium-vessel ischemic stroke

a Multicenter Prospective Randomized Controlled Trial of Intra-artErial thrombolysiS for aCUte Ischemic strokE With Medium Vessel Occlusion (RESCUE MeVO)

The team will test whether giving tenecteplase directly into the artery helps adults with acute ischemic stroke caused by medium-vessel blockage or severe narrowing.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 282 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Second Hospital of Anhui Medical University (other)
• Locations: 6 sites (Fuyang, Anhui and 5 other locations)
• Trial ID: NCT07185022 on ClinicalTrials.gov

What this trial studies

RESCUE MeVO is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial that assigns adults with acute ischemic stroke from medium-vessel occlusion or severe stenosis to best medical management alone or to best medical management plus intra-arterial thrombolysis. The intra-arterial treatment uses rhTNK-tPA infused proximal to the lesion for 5–30 minutes, with continuation guided by intraprocedural digital subtraction angiography. Eligible patients are adults with relevant arterial-segment occlusion or ≥70% stenosis, NIHSS scores typically 5–25 (or 3–4 with disabling deficits), and presentation within 24 hours including wake-up strokes, provided imaging shows no large established infarct and good collaterals. The primary outcome is excellent functional recovery (mRS 0–1) at 90 days and safety outcomes include symptomatic intracranial hemorrhage and procedural complications.

Who should consider this trial

Good fit: Adults (>18) presenting within 24 hours of symptom onset or last known well with imaging-confirmed medium-vessel occlusion or ≥70% stenosis, NIHSS 5–25 (or 3–4 with disabling deficits), and no large CT hypodensity are the ideal candidates.

Not a fit: Patients with large established infarcts on CT, poor collateral circulation, active bleeding or other thrombolysis contraindications, or those outside the treatment window are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could increase the proportion of patients who recover with no or minimal disability after medium-vessel stroke.

How similar studies have performed: Large randomized trials (DISTAL, ESCAPE-MeVO) showed no clear benefit for endovascular therapy in MeVO, while intra-arterial thrombolysis has supportive case-series and observational data but lacks randomized evidence.

Eligibility criteria

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

Where this trial is running

Fuyang, Anhui and 5 other locations

• Fu Yang People's Hospital — Fuyang, Anhui, China (RECRUITING)
• Lin Quan People's Hospital — Fuyang, Anhui, China (RECRUITING)
• The Second (Affiliated) Hospital of Anhui Medical University — Hefei, Anhui, China (RECRUITING)
• Shucheng People's Hospital — Lu'an, Anhui, China (RECRUITING)
• LiuZhou Worker's Hospital — Liuzhou, Guangxi, China (RECRUITING)
• Lishui Central Hospital — Lishui, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Qi Li, professor — The Second Hospital of Anhui Medical University
• Study coordinator: Qi Li, professor

Conditions: Stroke, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Ischemic Stroke, Infarction, Medium Vessel Occlusion