New combo device may catch more Stroke-Causing debris during artery stenting
NCT ID NCT07247864
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times
Summary
This study compares two methods to protect the brain during a procedure to open a narrowed neck artery (carotid stenting). The standard method uses a small filter to catch debris, but some particles may still reach the brain. The new method adds a balloon that temporarily stops blood flow and allows suction to remove debris. About 296 people with significant artery narrowing will be randomly assigned to one of the two methods. The main goal is to see if the combined approach reduces new brain spots seen on MRI within 3 days after the procedure.
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
-
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
-
About 296 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Dec 2027
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 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 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. Symptomatic extracranial carotid artery stenosis (occurrence of transient ischemic attack or non-disabling stroke in the ipsilateral carotid territory within the previous 6 months, with stenosis of 50% or greater) or asymptomatic extracranial carotid artery stenosis (stenosis of 70% or greater) meeting the indications for interventional treatment (stenosis degree measured by the NASCET method); 3. Pre-treatment modified Rankin Scale (mRS) score of 0 to 1; 4. Planned for stent treatment by the clinical care team; 5. Informed consent obtained from the patient or their legally authorized representative. Exclusion Criteria: 1. Occlusion or severe stenosis (70% or greater) of the intracranial segment of the ipsilateral internal carotid artery system; 2. Occlusion or severe stenosis (70% or greater) of the contralateral common carotid artery or internal carotid artery; 3. History of stenting in the head and neck vessels within 3 months; 4. Coexisting other cerebrovascular diseases, such as intracranial aneurysms greater than 5 mm or cerebrovascular malformations; 5. Onset of stroke within 7 days; 6. Large old infarctions from previous stroke that may confound the evaluation of endpoints; 7. Contraindications to magnetic resonance imaging (MRI); 8. Definite risk of cardiogenic embolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indications for anticoagulation therapy; 9. Absolute or relative contraindications to antiplatelet therapy; 10. Pregnant or lactating women; 11. Allergy or hypersensitivity to contrast media or stent materials (e.g., Nitinol); 12. Life expectancy less than 1 year; 13. Pre-existing neurological or psychiatric disorders (e.g., severe dementia) that would confound neurological assessments; 14. Severe renal insufficiency (eGFR less than 30 mL/min).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Carotid artery stenosis are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Beijing Anzhen Hospital Affiliated to Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 101118, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which patch keeps the carotid artery open longer?
- Can a new CT scanner see carotid plaques better?
- Could an arthritis drug shield heart and kidneys in metabolic syndrome?
- Could a double-barrel cholesterol drug shrink artery plaque better than statins alone?
- Balloon catheter may shield the brain from debris during artery stenting
- Blood test may flag heart danger before carotid surgery