Stent after clot removal: a new hope for stroke patients?
NCT ID NCT07356284
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 342 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2030
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 to 80 years
- 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: 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.
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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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ProMedica Toledo Hospital
RECRUITINGToledo, Ohio, 43606, United States
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