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New stroke trial aims to restore blood flow in tiny brain vessels

NCT ID NCT06904911

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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Other studies related to the condition(s) this trial covers.