NCT06949228RecruitingPhase 2/3
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 17 Apr 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 30 May 2028
- Lead sponsor
- ProMedica Health System
- Diseases
- Stroke
- NCT number
- NCT06949228
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 132
- From 30 Jul 2025 to the primary completion date, 30 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Platelet count \<100,000
- Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.7
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ProMedica Toledo Hospital Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.