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Stent after clot removal: a new hope for stroke patients?

NCT ID NCT07356284

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether placing a stent in the brain artery after removing a clot can improve recovery for people having a severe stroke. About 342 adults aged 18-80 with a blocked large artery and significant residual narrowing will be randomly assigned to get either standard clot removal alone or clot removal plus a stent. The goal is to see if the stent leads to better function and fewer complications like bleeding in the brain.

What this could mean

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

Active substance
Mechanical thrombectomy plus adjunct stenting
What this could lead to
If successful, this could establish a safer and more effective way to treat certain strokes caused by both a clot and a narrowed artery, potentially reducing long-term disability.
What could go wrong
This is a Phase 3 trial, but the added stenting procedure carries risks like bleeding or further vessel damage. The benefit over standard clot removal alone is not yet proven.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 342 people

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

Started

May 2026

Expected to finish

Jun 2030

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 to 80 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. 18 to 80 years of age 2. Presenting with symptoms consistent with AIS 3. Imaging evidence of an anterior occlusion of the Internal Carotid Artery (ICA) or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND residual 70-99% stenosis of the index artery following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling 4. NIHSS ≥ 6 5. Ability to randomize within 24 hours of stroke onset. 6. Pre-stroke mRS score 0-2 7. Ability to obtain signed informed consent. 8. ASPECTS Score ≥ 6 by non-contrast CT scan 9. Score-ICAD score of ≥11 points at screening and/or persistent stenotic occlusion of ≥70% after MT 10. If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay. 11. For subjects presenting \>6 hours from stroke onset, infarct core volume \<50 cc quantified by CTP Exclusion Criteria: 1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test 2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications. 3. CT evidence of the following conditions: * Midline shift or herniation * Evidence of intracranial hemorrhage * Mass effect with effacement of the ventricles 4. Acute bilateral strokes 5. Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents 6. Intracranial tumors other than small meningioma, that do not require surgery for at least one year post randomization. Small meningioma is defined as a lesion measuring ≤20mm in maximum diameter or ≤4cm3 in volume, with no associated mass effect, peritumoral edema, or progressive neurological symptoms 7. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>3.0 or Partial Thromboplastin Time (PTT) \>3 times of normal 8. Baseline platelet count \<80,000 per microliter (µl) 9. Life expectancy less than one year prior to stroke onset 10. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes. 11. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed 12. New diagnosis of atrial fibrillation or a history of atrial fibrillation 13. Suspected device-induced vasospasm defined as smooth transient narrowing of the target vessel 14. Vessel dissection including any of the following: presence of dissection flap, false lumen, contrast stagnation in the vessel wall, and/or improving stenosis \-

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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

  • ProMedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

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