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

Starting soon · Not applicable

Conditions studied: Carotid Artery Stenosis (Symptomatic and Asymptomatic)

In brief

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.

Key facts

Study ID

NCT07576790

Run by

Instituto de Investigación Marqués de Valdecilla

People needed

126

Starts

2026-07-01

Expected to finish

2027-12-31

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Symptomatic or asymptomatic carotid artery stenosis
• Candidate for carotid artery stenting
• Written informed consent provided

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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