RECRUITING

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

Conditions

Ischemic Stroke Acute Disease Stroke TNK Thrombolytic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-15

Study Completion:2028-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06949228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Syed Fazal Zaidi, MD

CONTACT

(419)- 291-8027

Syed.Zaidi2@utoledo.edu

Tanya Siddiqui

CONTACT

4192913498

Study Locations (Sites)

ProMedica Toledo Hospital

Toledo, Ohio, 43606

United States

Collaborators and Investigators

Sponsor: ProMedica Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-15

Study Completion Date2028-05-30

Study Record Updates

Study Start Date2025-06-15

Study Completion Date2028-05-30

Terms related to this study

Keywords Provided by Researchers

Stroke
TNK
Thrombolytic

Additional Relevant MeSH Terms

Ischemic Stroke
Acute Disease