Tests tenecteplase given into the artery after clot removal in stroke
Tests tenecteplase, a clot-dissolving drug, in adults with acute ischemic stroke after thrombectomy.
Plain-language title generated from the registry record
Registry title: Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
Key facts
- Where
- Toledo, United StatesSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06949228, who can take part
Where in United States
- ProMedica Toledo HospitalToledo, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ProMedica Health System
- Trial code
- NCT06949228
- Record updated
- 21 January 2026
- Original description
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.Read full original descriptionShow less
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
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.
Inclusion: Age 18-85; 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; Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT); Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher; Ability to obtain signed informed consent prior to randomization from LAR or Subject.
Exclusion: Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting); Previous known allergy to TNK; Major surgery in past 30 days; History of acute ischemic stroke in the last 60 days and/or has received previous treatment with a thrombolytic within the last 90 days; Concurrent enrollment in another trial that could confound the results of this study; Imaging evidence of hemorrhage or mass effect at baseline; History of intracranial hemorrhage or serious head trauma at any time; Any condition in the opinion of the enrolling physician that would preclude the patient from participating; Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation; Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) that is refractory to treatment; Any terminal medical condition with life expectancy less than 6 months; Platelet count <100,000; Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR >1.7; Premorbid modified Rankin scale (mRS) score >1; Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; Pregnant or lactating; Patient is on or requires dialysis; Presumed septic embolus; suspicion of bacterial endocarditis; Suspicion of aortic dissection; Intracranial neoplasm; Patient is unlikely to return for 90-day follow-up; Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK.