Balloon guide catheter plus filter protection during carotid artery stenting

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, controlled trial compares standard distal filter protection alone versus a combined approach that adds a balloon guide catheter to allow temporary flow arrest and aspiration during carotid artery stenting. Eligible adults have extracranial carotid stenosis (symptomatic ≥50% or asymptomatic ≥70%) and a pre-treatment mRS of 0–1 and are randomized to one of the two protection strategies. The trial focuses on whether the combined technique lowers the risk of dislodged plaque debris causing new clinical strokes or imaging-detected silent brain infarctions around the time of the procedure. Procedures follow standard CAS techniques using the assigned protection devices, with clinical and imaging follow-up to capture periprocedural ischemic events and new lesions.

Why it matters

Who can join: the full rules

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).

Where it's running

• Beijing Anzhen Hospital Affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaochuan Huo, Doctor, Doctor
• Email: hxc810909@163.com
• Phone: +86 13716292262

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.