Balloon catheter may catch brain clots during artery stenting
NCT ID NCT07576790
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using a balloon guide catheter during carotid artery stenting can prevent small particles from traveling to the brain and causing strokes. About 126 people with narrowed neck arteries will be randomly assigned to receive the balloon protection or standard stenting. Researchers will use MRI scans to check for brain damage within two days and track strokes or other complications for 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- balloon guide catheter
- What this could lead to
- If it works, this could make carotid stenting safer by reducing the chance of stroke during the procedure.
- What could go wrong
- This is a small, early-stage trial with only 126 participants, so results may not apply to everyone. The device may not reduce stroke risk as hoped.
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 126 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * Symptomatic or asymptomatic carotid artery stenosis * Candidate for carotid artery stenting * Written informed consent provided Exclusion Criteria: * Vascular anatomy unsuitable for balloon guide catheter placement * Severe renal failure * Previous disabling stroke or symptomatic intracranial hemorrhage * Evidence of carotid thrombus * Severe common carotid artery lesion * Chronic atrial fibrillation on oral anticoagulation * Acute coronary syndrome within 30 days * Contraindications to anticoagulant or antiplatelet therapy * Contraindications to MRI * Contrast media allergy * Lack of prior dual antiplatelet therapy
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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 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
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