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New drug could keep stents open after stroke, reducing need for rescue therapy

NCT ID NCT06813651

Disease control Sponsor: ThromBio Pty. Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called TBO-309 in 78 people having a stroke caused by a blocked artery in the neck and brain. The drug is given through a vein during standard clot-removal and stenting procedures. The goal is to see if TBO-309 can keep the stent open without causing dangerous 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 78 people

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

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Patient aged 18 years or more 2. Patient has an AIS due to tandem occlusion, including large vessel occlusion (LVO) within the intra-cranial anterior circulation and presumed atherosclerotic occlusion of the cervical internal carotid artery origin 3. CT perfusion indicates the presence of salvageable brain tissue, defined as ischaemic core \<70mL with a mismatch ratio \>1.8 and absolute mismatch \>15mL. 4. Patient has at least a mild grade of neurological impairment (NIHSS \>4) 5. Patient has an estimated pre-stroke mRS of less than 4 Exclusion Criteria: 1. Patient is considered unlikely to benefit from study intervention defined by one of the following: 1. Advanced dementia 2. Severe pre-stroke disability (mRS score 4-5) 3. Glasgow Coma Score (GCS) 3 to 5 4. Evidence of a large well-defined ischaemic lesion measuring more than one third of the middle cerebral artery (MCA) territory 2. Uncontrolled hypertension (SBP \>180 or DBP \>110, refractory to medical therapy) 3. Intracranial haemorrhage within the last 90 days 4. Myocardial infarction or stroke within the last 30 days 5. Patient has an underlying disease process with a life expectancy of \<90 days 6. Known treatment with anticoagulants 7. Known severe liver disease 8. Known bleeding disorder 9. Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days 10. Another medical illness or social circumstance that may interfere with outcome assessments and follow-up 11. Known or suspected pregnancy 12. Patients currently participating in another interventional clinical trial 13. Informed consent unable to be obtained from the patient or their Person Responsible/Medical Treatment Decision Maker prior to study interventions

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke Tandem occlusion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • John Hunter Hospital

    RECRUITING

    Newcastle, New South Wales, 2305, Australia

  • Royal North Shore Hospital

    NOT_YET_RECRUITING

    St Leonards, New South Wales, 2065, Australia

More trials for these conditions

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