NCT07576790Not yet recruitingNot Applicable
Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting: A Randomized Study (EMBO-PROTECT)
Instituto de Investigación Marqués de Valdecilla0 sites126 target enrollmentStarted: July 1, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 126
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors (neurologists and radiologists evaluating diffusion-weighted MRI images) are blinded to treatment allocation. Participants and interventional staff are not blinded due to the nature of the procedure.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
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