RECRUITING Phase 3 ClinicalTrials.gov

Intra-arterial Thrombolysis For Acute Ischemic Stroke With Medium Vessel Occlusion

Sponsor: The First Affiliated Hospital with Nanjing Medical University • ClinicalTrials.gov ID: NCT07668323

Registry updated: 2026-09-23

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Description

A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) phase III trial is planned to evaluate the efficacy and safety of intra-arterial thrombolysis (IAT) in patients with acute ischemic stroke caused by medium vessel occlusion (MeVO, distal M2 \[above the mid-insular height\], M3 or M4; A2, A3 or A4; or P2 or P3 segments, confirmed by CTA or MRA), compared with best medical management alone. Eligible participants (aged 18-80 years, baseline NIHSS score 6-25, confirmed MeVO within 24 hours of symptom onset or last known well) will be randomly assigned 1:1 to the intra-arterial thrombolysis plus best medical management group or the best medical management alone group. The primary endpoints are (i) the proportion of patients with a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-2 at 90±7 days post-randomization; (ii) the proportion of patients with symptomatic intracranial hemorrhage (sICH) within 48 hours post-randomization, defined and classified according to the Heidelberg Bleeding Classification; and (iii) the proportion of patients with early neurological deterioration (END) within 7 days post-randomization, defined as an increase of ≥ 4 points in the total NIHSS score from baseline or an increase of ≥ 2 points in any single NIHSS item. Secondary endpoints: 1. Procedure-related complications within 24 hours post-randomization; 2. Recanalization rate (meTICI ≥ 2b) at 24±12 hours post-randomization; 3. Any intracranial hemorrhage within 48 hours post-randomization; 4. Early neurological improvement (NIHSS score change from baseline) at 7 days or discharge; 5. Overall distribution of mRS scores at 90±7 days (shift analysis); 6. Excellent functional outcome (mRS score 0-1) at 90±7 days; 7. Functional independence (Barthel Index score 95 or 100) at 90±7 days; 8. Health-related quality of life (EQ-5D-5L) at 90±7 days; 9. All-cause mortality within 90±7 days.

Interventions

Recombinant Tissue Plasminogen Activator (rt-PA) (Drug)
Administered intra-arterially via microcatheter. Agent options: alteplase (rt-PA) at 0.225 mg/kg (maximum 22.5 mg) or tenecteplase (TNK) at 0.0625 mg/kg (maximum 6.25 mg), infused over 15-30 minutes. The choice of agent should be consistent with any prior intravenous thrombolysis.
Intra-arterial Thrombolysis (Procedure)
Microcatheter is navigated to the occluded medium vessel. For small thrombus burden, positioned adjacent to or within the thrombus. For larger burden, advanced through occluded segment with staged administration distal-to-proximal (one-third per segment). Procedure ends at meTICI ≥ 2b or when risks outweigh benefits.
Best Medical Management (Drug)
Best medical management per local guidelines, including antiplatelet therapy, anticoagulation (if indicated), statins, blood pressure and glycemic control, and rehabilitation.
Rescue therapy (Procedure)
Rescue intra-arterial thrombolysis is permitted in both treatment groups, including participants randomized to best medical management alone, if neurological deterioration occurs after randomization, defined as an increase of ≥ 4 points in the NIHSS score from baseline after exclusion of non-stroke causes such as hypoglycemia, infection, or metabolic derangement, with imaging evidence of salvageable brain tissue (Tmax \> 6 s volume ≥ 10 mL and core infarct volume \[rCBF \< 30%\] \< 50% of the Tmax \> 6 s volume), and provided that rescue therapy can be initiated within 24 hours of symptom onset or last known well. Rescue endovascular therapy is limited to intra-arterial thrombolysis and administered with same agents (alteplase or tenecteplase) at the same doses specified for the intra-arterial thrombolysis intervention; thrombectomy devices, balloon angioplasty, and stenting are not permitted.

Eligibility criteria

Inclusion Criteria: * Age 18 to 80 years. * Time from symptom onset or last known well to randomization within 24 hours. * Clinical diagnosis of acute ischemic stroke confirmed by CTA or MRA as being caused by isolated acute medium vessel occlusion, including distal M2/M3/M4 segments of the middle cerebral artery, A2/A3/A4 segments of the anterior cerebral artery, or P2/P3 segments of the posterior cerebral artery. Isolated occlusion is defined as a single symptomatic vessel occlusion; patients with multiple vessel occlusions or uncertain culprit vessel are excluded. * Baseline NIHSS score ≥ 6, and NIHSS score ≤ 25 at the time of randomization. * For patients presenting beyond 6 hours from symptom onset: perfusion imaging criteria require a Tmax \> 6 s volume ≥ 10 mL and a core infarct volume (defined as rCBF \< 30%) \< 50% of the Tmax \> 6 s volume. * Patient or legally authorized representative is able to understand and voluntarily sign the informed consent form. Exclusion Criteria: * Clinical Exclusion Criteria: * Pre-stroke modified Rankin Scale (mRS) score \> 2. * Presence of contraindications to intravenous thrombolysis. * Known allergy to heparin, contrast media, anesthetics, or other definite contraindications to endovascular treatment. * Comorbid severe diseases that may affect outcome assessment, including but not limited to malignancy, severe heart failure, or renal failure, with expected life expectancy \< 6 months. * Uncontrolled hypertension refractory to medical therapy (systolic blood pressure \> 220 mmHg or diastolic blood pressure \> 120 mmHg). * Baseline blood glucose \< 2.8 mmol/L (50 mg/dL) or \> 22.2 mmol/L (400 mg/dL). * Known bleeding diathesis, including but not limited to: platelet count \< 100 × 10⁹/L; heparin treatment within 48 hours with APTT ≥ 35 seconds; oral warfarin with INR \> 3. Note: Patients without a history or suspicion of coagulation disorders do not require laboratory testing for coagulation parameters prior to enrollment. * Stroke onset with seizure or seizure occurring during the course of stroke, precluding accurate determination of baseline NIHSS score. * Female patients who are pregnant, lactating, or have a positive pregnancy test at hospital admission. * Currently participating in another investigational drug or device study that may interfere with the results of this study. * Other conditions judged by the investigator to be unsuitable for participation or posing significant risk to the patient. * Imaging Exclusion Criteria: * Intracranial hemorrhage confirmed by baseline head CT or MRI, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or subdural/epidural hemorrhage. * Presence of midline shift or cerebral herniation, or other ventricular mass effect with midline shift. * Anticipated inability to complete endovascular treatment due to vascular tortuosity, severe vessel wall calcification, or other anatomical challenges. * Aortic dissection. * Multiple vessel occlusions confirmed by CTA or MRA with inability to identify the symptomatic culprit vessel, such as bilateral middle cerebral artery occlusion or concurrent middle cerebral artery and basilar artery occlusion. * Suspected or confirmed non-acute occlusion of the symptomatic culprit vessel.

Conditions

Medium Vessel Occlusion Ischemic Stroke, Acute

Locations

the First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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