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NCT06949228PHASE2, PHASE3Recruiting

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial

ProMedica Health System

Start Date

7/30/2025

Completion Date

5/30/2028

Summary

The study objective is to evaluate the safety and efficacy of Intra arterial (IA) Tenecteplase (TNK) as an adjunctive therapy in acute ischemic stroke (AIS) patients with large vessel occlusions (LVO) in the anterior circulation of Internal Carotid Artery (ICA), Middle Cerebral Arteries (M1 and M2) who achieve a reperfusion grade of Modified Treatment in Cerebral Ischemia Scale (mTICI) 2b or higher post-mechanical thrombectomy using Food and Drug Administration (FDA) approved devices.

Eligibility Criteria

Age Range: 18 years to 85 years

Inclusion Criteria: 1. Age 18-85 2. Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well 3. Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT) 4. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher. 5. Ability to obtain signed informed consent prior to randomization from LAR or Subject Exclusion Criteria: 1. Premorbid modified Rankin scale (mRS) score \>1 2. Imaging evidence of hemorrhage or mass effect at baseline 3. Platelet count \<100,000 4. Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency 5. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.7 6. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting) 7. Pregnant or lactating 8. Previous known allergy to TNK 9. Major surgery in past 30 days 10. Patient is on or requires dialysis 11. History of intracranial hemorrhage or serious head trauma at any time 12. Any condition in the opinion of the enrolling physician that would preclude the patient from participating 13. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation 14. Severe, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) that is refractory to treatment 15. History of acute ischemic stroke in the last 60 days and/or has received previous treatment with a thrombolytic within the last 90 days 16. Presumed septic embolus; suspicion of bacterial endocarditis 17. Suspicion of aortic dissection 18. Intracranial neoplasm 19. Any terminal medical condition with life expectancy less than 6 months 20. Concurrent enrollment in another trial that could confound the results of this study 21. Patient is unlikely to return for 90-day follow-up. 22. Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK

Interventions

DRUG

tenecteplase

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Conditions

Ischemic StrokeAcute Disease

Locations

ProMedica Toledo Hospital

Toledo, Ohio 43606

United States