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Could a direct brain injection of a Clot-Buster boost stroke recovery?

NCT ID NCT05172934

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether giving a clot-busting drug called tenecteplase directly into the brain artery, right after a standard procedure to remove a clot, can help people who have had a severe ischemic stroke. The study includes adults aged 18-85 with a blocked artery in the front part of the brain, treated within 24 hours of symptoms. Participants receive the drug after successful clot removal and are followed for three months to check for bleeding and measure their recovery and disability levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intra-arterial tenecteplase
What this could lead to
If successful, this approach could improve recovery and reduce disability after a major stroke by clearing residual clots that standard treatment leaves behind.
What could go wrong
This is a small pilot study, so results may not apply broadly. The main risk is bleeding in the brain, which the trial closely monitors.

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

20 people

The number who actually took part.

Started

Apr 2022

Finished

Nov 2023

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 to 85 years

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: * 1\. Age 18-85 * 2\. Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well * 3\. a. Patients treated less than 6 hours since last known well with ASPECTS \>6. b. Patients treated beyond 6 hours since last known well, CT or MRI perfusion scan showing favorable mismatch profile (Target mismatch profile on CT perfusion or MRI (ischemic core volume is \<70ml, mismatch ratio is \>1.8 and mismatch volume is \>15ml) * 4\. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or 2c with persistent occlusion(s) in terminal branches not amenable to MT. * 5\. Signed informed consent Exclusion Criteria: * 1\. Premorbid modified Rankin scale (mRS) score of 4 or greater * 2\. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT * 3\. Platelet count \<100,000 * 4\. Known bleeding diathesis * 5\. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency * 6\. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.8 * 7\. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting) * 8\. Pregnant or lactating * 9\. Previous known allergy to TNK * 10\. Major surgery in past 30 days * 11\. Patient is on or requires dialysis * 12\. History of intracranial hemorrhage or serious head trauma at any time * 13\. Any condition in the opinion of the enrolling physician that would preclude the patient from participating * 14\. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation * 15\. Severe, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) that is refractory to treatment * 16\. History of acute ischemic stroke in the last 60 days * 17\. Presumed septic embolus; suspicion of bacterial endocarditis * 18\. Suspicion of aortic dissection * 19\. Intracranial neoplasm * 20\. Any mass effect * 21\. Any terminal medical condition with life expectancy less than 6 months * 22\. Concurrent enrollment in another trial that could confound the results of this study

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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.

Contacts and locations

Locations

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606, United States

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