Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial.
Syed F Zaidi, Alicia C Castonguay, Osama O Zaidat...
https://pubmed.ncbi.nlm.nih.gov/39772606Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 85Years
All Genders
ID06949228
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
Led by ProMedica Health System · Updated on 2026-01-21
132
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of intra-arterial Tenecteplase (TNK) as an additional treatment in adults with acute ischemic stroke caused by large vessel blockages in the anterior circulation of the brain (Internal Carotid Artery and Middle Cerebral Arteries M1 and M2 segments). This Phase 2 and 3 trial focuses on patients who have undergone mechanical thrombectomy using FDA-approved devices and achieved successful reperfusion (mTICI 2b or higher). The goal is to see if adding TNK improves recovery outcomes after stroke. Participants will be randomly assigned to receive either intra-arterial TNK following their mechanical thrombectomy or the best medical care without TNK. The study compares these two approaches to evaluate treatment benefits and risks. This trial will enroll adults aged 18 to 85 years who meet specific clinical and imaging criteria related to their stroke and thrombectomy results. During the study, patients will be monitored closely with assessments including the Modified Rankin Scale (mRS) at 90 days to measure disability, along with safety checks such as monitoring for brain hemorrhage and neurological worsening within 24 hours after treatment. Additional outcomes like functional independence, mortality rates, revascularization grades, and infarct volume will also be tracked. The total follow-up period includes visits up to 90 days after treatment to evaluate both efficacy and safety.
CONDITIONS
Brief Title
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years
- Symptoms of anterior circulation ischemic stroke with confirmed occlusion in Internal Carotid Artery, M1, or M2 segments
- Mechanical thrombectomy started within 24 hours of last known well
- Alberta Stroke Program Early CT Score (ASPECTS) 6 or higher on baseline non-contrast head CT
- Post-mechanical thrombectomy with 5 or fewer device passes and mTICI grade 2b or higher
- Signed informed consent obtained from legally authorized representative or subject prior to randomization
You will not qualify if you...
- Premorbid modified Rankin scale score greater than 1
- Evidence of hemorrhage or mass effect on baseline imaging
- Platelet count below 100,000
- Active hemorrhagic or coagulation disorders
- Use of novel oral anticoagulants within last 48 hours or INR over 1.7
- Need for dual antiplatelet therapy (e.g., carotid artery stenting)
- Pregnant or lactating women
- Known allergy to Tenecteplase
- Major surgery within past 30 days
- On or requiring dialysis
- History of intracranial hemorrhage or serious head trauma
- Conditions that would interfere with participation or evaluation
- Severe uncontrolled hypertension resistant to treatment
- Stroke within last 60 days or thrombolytic treatment within last 90 days
- Suspected septic embolus or bacterial endocarditis
- Suspected aortic dissection
- Intracranial tumor
- Terminal illness with life expectancy under 6 months
- Participation in conflicting clinical trials
- Unlikely to complete 90-day follow-up
- Concurrent intravenous tissue plasminogen activator administration with intra-arterial Tenecteplase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment procedure
Participants receive either intra-arterial Tenecteplase following mechanical thrombectomy or best medical practice treatment.
1 treatment visit (in-person)
Follow-up
Duration - Up to 90 days post treatment
Participants are monitored for safety and efficacy outcomes after treatment, including assessments of neurological status and brain imaging.
Approximately 3 visits: at 24 hours, discharge (around Day 6), and 90 days post treatment
Trial Site Locations
Total: 1 location
1
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
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Research Team
S
Syed Fazal Zaidi, MD
T
Tanya Siddiqui
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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