After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better
NCT ID NCT07026331
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial compares two rescue procedures for people who have a stroke caused by a hardened, narrowed brain artery that still has significant blockage after initial endovascular treatment. About 486 participants will be randomly assigned to receive either balloon angioplasty or stenting to open the remaining narrowing. The main question is whether balloon angioplasty is as good as stenting at helping people regain independence within 90 days. Researchers will also track safety, including bleeding in the brain and death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Balloon angioplasty or stenting as a rescue procedure after endovascular treatment for stroke
- What this could lead to
- If balloon angioplasty works as well as stenting, it could offer a simpler, safer rescue option for people with stroke caused by narrowed brain arteries, potentially improving their chances of independent recovery.
- What could go wrong
- This is an open-label trial, so doctors know which treatment each patient gets, which can introduce bias. The procedure itself carries risks like bleeding in the brain, and the outcome depends on many factors beyond the choice of rescue technique.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 486 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2027
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 years and older
- 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. Age 18 years or older. 2. Pre-stroke modified Rankin Scale (mRS) score of 0-1. 3. Symptoms of acute ischemic stroke presenting within 24 hours of the last known well time. 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score of at least 6. 5. Baseline Alberta Stroke Program Early CT Score (ASPECTS) of at least 6 for anterior-circulation stroke, or posterior-circulation ASPECTS (pc-ASPECTS) of at least 6 for posterior-circulation stroke. 6. Occlusion of the intracranial internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, or basilar artery. 7. The clinical care team plans to perform endovascular treatment. 8. The participant or the participant's legally authorized representative is able to provide written informed consent. 9. Baseline CT perfusion or MR perfusion imaging demonstrating an ischemic core volume of less than 70 mL, a mismatch ratio of at least 1.2, and a mismatch volume of at least 15 mL. 10. Intracranial atherosclerosis is considered the underlying etiology, with residual stenosis of at least 50% after endovascular treatment, and rescue balloon angioplasty or stenting is planned Exclusion Criteria: 1. Any intracranial hemorrhage identified on imaging before randomization; or major intracranial hemorrhage, defined as parenchymal hematoma type 1 or type 2, identified on intraprocedural flat-panel CT. Parenchymal hematoma type 1 is defined as blood clots involving less than 30% of the infarcted area, with or without a slight space-occupying effect; parenchymal hematoma type 2 is defined as blood clots involving more than 30% of the infarcted area with a substantial space-occupying effect. 2. Gastrointestinal or genitourinary bleeding within 30 days before stroke onset, or major surgery within 14 days before stroke onset. 3. Bleeding diathesis, including platelet count below 100 × 10⁹/L, activated partial thromboplastin time greater than 50 seconds, or international normalized ratio greater than 2.0; treatment with a direct oral anticoagulant within the preceding 48 hours; or a history of heparin-induced thrombocytopenia. 4. Pregnancy or breastfeeding at admission. 5. Contraindication to iodinated contrast agents, nickel, titanium, or their alloys. 6. Life expectancy of less than 6 months. 7. Pre-existing neurological or psychiatric disease that may confound neurological or functional outcome assessment. 8. Severe renal impairment, defined as glomerular filtration rate below 30 mL/min or serum creatinine above 220 μmol/L (2.5 mg/dL). 9. Arterial tortuosity or another arterial condition that would prevent the study device from reaching the target vessel. 10. Unlikely to complete the 90-day follow-up. 11. Any definite cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, history of atrial or ventricular thrombus, myocardial infarction within the preceding 3 months, dilated cardiomyopathy, spontaneous echo contrast in the left atrium, or left ventricular ejection fraction below 30%. 12. Use of any glycoprotein IIb/IIIa inhibitor other than tirofiban.
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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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Beijing Anzhen Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 101118, China
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