Proximal Balloon Protection during Carotid Stenting in Carotid Stenosis

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 prospective, randomized study compares carotid artery stenting with proximal embolic protection via a balloon guide catheter to stenting without this protection. The goal is to see if the protected approach lowers the rate of new diffusion-weighted MRI-detected microembolisms and any symptomatic thromboembolic events. Participants are adults with symptomatic or asymptomatic carotid stenosis who are candidates for stenting. Safety and efficacy are assessed through imaging and clinical outcomes. The trial is conducted at a single center in Santander, Spain.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Universitario Marqués de Valdecilla
  Santander, Cantabria, Spain Recruiting

Study contacts

• Study coordinator: veronica vidal
• Email: veronica.vidal@idival.org
• Phone: 942203389

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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.