← Back to all trials
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
Source: ClinicalTrials.gov (NCT07576790). StuddyBuddy aggregates publicly available trial information.