Not Yet RecruitingNot Applicable

Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)

126 participantsStarted 2026-07-01

Plain-language summary

Carotid angioplasty and stenting (CAS) is an effective treatment for carotid artery stenosis but carries a risk of cerebral embolization. This prospective randomized study evaluates the safety and efficacy of proximal embolic protection using a balloon guide catheter during CAS by comparing the incidence of diffusion-weighted MRI-detected microembolisms and symptomatic thromboembolic events between protected and unprotected procedures.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence, number, and volume of new cerebral ischemic lesions detected by diffusion-weighted MRI within 48 hours after carotid artery stenting

Timeframe: Within 48 hours after the procedure

Trial details

NCT IDNCT07576790

SponsorInstituto de Investigación Marqués de Valdecilla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

Contact for this trial

veronica vidal

942203389 veronica.vidal@idival.org

View on ClinicalTrials.gov More Carotid Artery Stenosis (Symptomatic and Asymptomatic) trials