Is intra-arterial thrombolysis beneficial for M2 occlusions? Subgroup analysis of the PROACT-II trial.
Ralph Rahme, Todd A Abruzzo, Renee' Hebert Martin...
https://pubmed.ncbi.nlm.nih.gov/23223507Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID07357987
Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke: the ANGEL-MeVO-TNK Randomized Clinical Trial
Led by Beijing Tiantan Hospital · Updated on 2026-04-30
488
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating intra-arterial Tenecteplase (TNK) for treating acute ischemic stroke caused by medium vessel occlusion (MeVO) in adults aged 18 years and older. This phase III trial will enroll 488 patients who have a stroke with certain neurological deficits and specific vessel occlusions. The study compares the effects of TNK administered directly into the artery versus standard medical care, aiming to improve recovery measured by the modified Rankin Scale (mRS) score at 90 days and to assess safety outcomes such as symptomatic intracerebral hemorrhage (sICH). Participants will be randomized into one of two groups after providing consent. In the TNK group, patients who have not had intravenous thrombolysis (IVT) will receive a slow, continuous intra-arterial infusion of TNK in a stepwise manner with doses given over 15-minute intervals, up to specified maximum doses. Patients who have already received IVT will get a single 15-minute TNK infusion at a lower maximum dose. The control group will receive standard medical management according to current stroke guidelines. The infusion procedure involves angiographic assessments to determine the need for repeated dosing or termination of the treatment. After the procedure, all patients receive standard care. Participants will be followed through four visits: on the day of randomization, about 48 hours later, and again at 90 days post-randomization. During these visits, researchers will collect demographic data, clinical signs, laboratory tests, neuroimaging, and neurological function scores. The main outcomes include the proportion of patients achieving good functional recovery (mRS 0-1) at 90 days and monitoring for brain bleeding within 48 hours. Additional outcomes such as stroke severity changes, recanalization rates, infarct size, and mortality will also be assessed throughout the study period.
CONDITIONS
Brief Title
Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pre-stroke modified Rankin Scale score of 0 or 1
- Stroke symptom onset within 24 hours
- Baseline NIH Stroke Scale score greater than 5, or score 3 to 5 with disabling deficits such as motor, language, or vision problems
- Informed consent obtained from patient or legal representative
- Imaging confirming isolated medium vessel occlusion in specified artery segments
- Ischemic infarct volume less than 50% of the territory supplied by the occluded artery
You will not qualify if you...
- Acute intracranial hemorrhage
- ASPECT score 5 or less
- Medium vessel occlusion due to thrombus fragmentation or after prior thrombolysis or thrombectomy
- Contraindication to Tenecteplase
- Severe allergy to contrast agents (excluding mild rash)
- Use of heparin or novel oral anticoagulants within 48 hours with INR 1.7 or higher
- Major bleeding history within 6 months or active gastrointestinal ulcer, aortic dissection, low platelet count
- Presence of vascular malformations, arterial dissection, large aneurysms, tumors (except small meningiomas), cerebral vasculitis, amyloid angiopathy, or other major non-ischemic brain diseases
- Acute renal failure, dialysis, or low kidney function (eGFR less than 30 ml/min/1.72m2 or high serum creatinine)
- Severe liver disease or significant liver enzyme abnormalities
- Severe non-cardiovascular disease with life expectancy less than 3 months
- Known pregnancy, breastfeeding, or positive pregnancy test
- Participation in another drug or device trial
- Any other condition making participation unsafe or unsuitable, including inability to comply due to psychiatric or cognitive issues
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 session with procedure lasting up to approximately 30 minutes
Participants receive intra-arterial Tenecteplase as a slow infusion for thrombolysis or standard medical management according to current guidelines.
1 procedure visit (in-person)
Follow-up
Duration - Up to 90 days after treatment
Participants are monitored for recovery and safety outcomes following treatment.
Visits at 24 hours, 48 hours, and approximately 90 days after treatment
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
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Research Team
L
Liping Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Clinical Course of Acute Ischemic Stroke Due to Medium Vessel Occlusion With and Without Intravenous Alteplase Treatment.
Johanna M Ospel, Bijoy K Menon, Andrew M Demchuk...
https://pubmed.ncbi.nlm.nih.gov/33070714A simple, assumption-free, and clinically interpretable approach for analysis of modified Rankin outcomes.
George Howard, Jennifer L Waller, Jenifer H Voeks...
https://pubmed.ncbi.nlm.nih.gov/22343650Intra-arterial Tenecteplase for Acute Stroke After Successful Endovascular Therapy: The ANGEL-TNK Randomized Clinical Trial.
Zhongrong Miao, Gang Luo, Ligang Song...
https://pubmed.ncbi.nlm.nih.gov/40616323Tenecteplase vs Alteplase for Patients With Acute Ischemic Stroke: The ORIGINAL Randomized Clinical Trial.
Xia Meng, Shuya Li, Hongguo Dai...
https://pubmed.ncbi.nlm.nih.gov/39264623Randomized trial of intraarterial infusion of urokinase within 6 hours of middle cerebral artery stroke: the middle cerebral artery embolism local fibrinolytic intervention trial (MELT) Japan.
Akira Ogawa, Etsuro Mori, Kazuo Minematsu...
https://pubmed.ncbi.nlm.nih.gov/17702958Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion.
Mayank Goyal, Johanna M Ospel, Aravind Ganesh...
https://pubmed.ncbi.nlm.nih.gov/39908448Endovascular Treatment for Stroke Due to Occlusion of Medium or Distal Vessels.
Marios Psychogios, Alex Brehm, Marc Ribo...
https://pubmed.ncbi.nlm.nih.gov/39908430Endovascular Versus Medical Management in Distal Medium Vessel Occlusion Stroke: The DUSK Study.
Mahmoud H Mohammaden, Lorena Souza Viana, Hend Abdelhamid...
https://pubmed.ncbi.nlm.nih.gov/38787927Endovascular Therapy vs Medical Management for Patients With Acute Stroke With Medium Vessel Occlusion in the Anterior Circulation.
Hamidreza Saber, Shashvat M Desai, Diogo Haussen...
https://pubmed.ncbi.nlm.nih.gov/36279137