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Recruiting NCT07576790

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

Conditions: Carotid Artery Stenosis (Symptomatic and Asymptomatic)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 126
Sponsor: Instituto de Investigación Marqués de Valdecilla

Location: Hospital Universitario Marqués de Valdecilla Santander Cantabria

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07576790). StuddyBuddy aggregates publicly available trial information.