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

Launched by PROMEDICA HEALTH SYSTEM · Apr 21, 2025

Keywords

ClinConnect Summary

The ALLY II Trial is a clinical study looking at a treatment called intra-arterial Tenecteplase (TNK) for patients who have suffered an acute ischemic stroke due to a blockage in the large blood vessels of the brain. This trial aims to see if using TNK alongside a procedure called mechanical thrombectomy (which removes the blockage) is safe and effective for improving recovery in patients. The study will include adults aged 18 to 85 who show specific signs of stroke and meet certain health criteria, like having a good score on a brain scan that measures damage.

If you or a loved one are eligible and choose to participate, you can expect to undergo a screening process to confirm your condition and overall health. Participants will receive the TNK treatment after their thrombectomy, and the study will monitor their recovery over 90 days to see how well they do. It's important to note that there are specific health conditions that might prevent someone from joining, such as severe bleeding disorders or recent surgeries. The trial is not currently recruiting, but it represents a potential advancement in stroke treatment for certain patients.

Gender

ALL

Eligibility criteria

• 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