A Phase 2 interventional study of Intra-arterial Tenecteplase and Intra-arterial Saline in Acute Ischemic Stroke, sponsored by Wake Forest University Health Sciences. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the safety and feasibility of using intra-arterial Tenecteplase in patients undergoing blood clot extraction for treatment of acute ischemic (non-bleeding) stroke. Intravenous Tenecteplase is FDA-approved to treat patients with an ischemic stroke presenting within the 0-3-hour time window.
The primary objective of this study is to determine the safety and feasibility of intra-arterial Tenecteplase in selected patients with persistent post-thrombectomy hypoperfusion on computed tomography perfusion based on symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage producing decline from the initial NIHSS of ≥ 4 points) at 24-36 hours.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of intra-arterial Tenecteplase (0.125 mg/kg, maximum dose 12.5 mg) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist.
Drug: Intra-arterial Tenecteplase
Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of saline (0.9% NaCl solution) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist.
Drug: Intra-arterial Saline
One-time dose of intra-arterial tenecteplase post-thrombectomy
One-time dose of intra-arterial saline post-thrombectomy
Participants with Change in Symptomatic Intracranial Hemorrhage
Number of participants with symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage) producing decline from the initial National Institutes of Health Stroke Scale (NIHSS) of ≥ 4 points.
Time frame: Hour 36
Participants with Parenchymal Hematoma Type 1
Number of participants with parenchymal hematoma type 1
Time frame: 24 Hours
Participants with Parenchymal Hematoma Type 2
Number of participants with parenchymal hematoma type 2
Time frame: 24 Hours
30-Day Mortality Count
Number of patients expired
Time frame: Day 30
90-Day Mortality Count
Number of patients expired
Time frame: Day 90
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Time frame: Hour 24
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Time frame: Day 5
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Time frame: Day 30
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Time frame: Day 90
Proportion of subjects achieving early neurological improvement
Proportion of subjects achieving early neurological improvement, defined as National Institutes of Health Stroke Scale (NIHSS) reduction by ≥ 4 points or total NIHSS 0-2
Time frame: Hour 24
Proportion of subjects achieving delayed neurological improvement
Proportion of subjects achieving delayed neurological improvement, defined as National Institutes of Health Stroke Scale (NIHSS) reduction by ≥ 4 points or total NIHSS 0-2
Time frame: Day 30, Day 90
Ordinal Modified Rankin Scale score
Modified Rankin scale scores range from 0-6. Higher score indicates greater disability.
Time frame: Day 90
Participants with Change in Modified Rankin Scale Score 0-2 Points
Number of participants with change in Modified Rankin Scale score of 0-2 points or return to baseline modified Rankin scale score.
Time frame: Day 90
Participants with Change in Modified Rankin Scale Score 0-1 Points
Number of participants with change in Modified Rankin Scale score of 0-1 points or return to baseline modified Rankin scale score.
Time frame: Day 90
Participants with Change in Modified Rankin Scale Score 0-3 Points
Number of participants with change in Modified Rankin Scale score of 0-3 points or return to baseline modified Rankin scale score.
Time frame: Day 90
Change in Infarct Volume
Change in infarct volume on follow up CT or MRI
Time frame: Hour 24
Barthel Index Score
Number of participants with Barthel Index score ≥ 95.
Time frame: Day 90
Median EuroQol-5-Dimension (EQ-5D) Index
Median EuroQol-5-Dimension (EQ-5D) index has a score range of -0.573 to 1. Higher score indicates better quality score.
Time frame: Day 90
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Jun 2028, 33 months after the start.
Of 83 non-industry phase 2 interventional studies under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 33 months is above that.
Counting every sponsor, half of 124 studies reached it within 28 months; a quarter within 15 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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