New stroke trial aims to restore blood flow in tiny brain vessels
NCT ID NCT06904911
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study tests whether giving the clot-busting drug tenecteplase directly into the brain artery after standard clot removal can improve blood flow in tiny vessels. About 20 adults who had a major stroke from a large clot will receive a single dose of the drug through a catheter. Researchers will measure changes in blood flow using special imaging and track recovery over 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tenecteplase (a clot-busting drug given directly into the brain artery)
- What this could lead to
- If it works, this could point toward a way to improve recovery after a major stroke by restoring blood flow in tiny brain vessels that standard treatment misses.
- What could go wrong
- This is a very small, early-phase trial with only 20 participants and no comparison group, so results may not hold up in larger studies. The drug also carries a risk of bleeding in the brain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient/legally authorized representative has signed the Informed Consent Form * At least 18 years of age * Ability to comply with the study protocol, in the investigator's judgment * Acute ischemic stroke attributed to anterior circulation large vessel occlusion (of the internal carotid artery or first segment of the middle cerebral artery based on CTA, MRA, or catheter angiogram) being treated with mechanical thrombectomy * NIHSS ≥ 6 at the initiation of endovascular therapy (arterial puncture) * Time from stroke onset to IA-TNK administration \< 24 hours. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline * ASPECTS ≥ 6 on pre-MT CT imaging * If treated \> 6 hours from stroke onset, CTP imaging must demonstrates favorable mismatch profile (based on RAPID processing: infarct core \<70 mL, mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 mL) * Qualifying neuroimaging (CT and CTP, if applicable) must be obtained \<120 minutes prior to arterial puncture. Exclusion Criteria: * Current participation in another investigational drug or device study * Known hypersensitivity or allergy to any ingredients of tenecteplase * Active internal bleeding * Known bleeding diathesis (Alzheimer's patients taking lecanemab) * Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR \> 1.7 * Use of one of the new oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban) * Treatment with a thrombolytic within the last 3 months prior to randomization, inclusive of intravenous thrombolysis during the index stroke. * Baseline platelet count \< 100,000/microliter (results must be available prior to treatment) * Baseline blood glucose \> 400 mg/dL (22.20 mmol/L) * Baseline blood glucose \< 50 mg/dL needs to be normalized prior to randomization * Intracranial or intraspinal surgery or trauma within 2 months * Other serious, advanced, or terminal illness (investigator's judgment) or life expectancy is less than 6 months * History of acute ischemic stroke in the last 90 days * History of hemorrhagic stroke * Presumed septic embolus; suspicion of bacterial endocarditis * Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was to be performed * Pregnant * Systolic BP \>185 mmHg or diastolic BP \>110 mmHg, refractory to treatment * Suspicion of aortic dissection * Known allergy to iodine or iodinated contrast * Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram * Renal failure as defined by a serum creatinine \> 3.0 mg/dl or GFR \< 30 * Known intracranial neoplasm * GI bleeding within the past 21 days * Pre-existing medical or neurological disease that will confound the neurological or functional evaluations * Premorbid (prior to the index stroke) modified Rankin Scale (mRS) score ≥ 3 Additional neuroimaging exclusion criteria: * ASPECTS \<6 on pre-MT CT imaging * Acute intracranial hemorrhage or contrast extravasation on CT before or immediately after MT (prior to study drug administration) * Significant mass effect with midline shift on non-contrast CT before or immediately after MT * Cervical or intracranial stent placement during endovascular therapy * Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA, MRA, or catheter angiography
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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