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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

126 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Single masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Instituto de Investigación Marqués de Valdecilla

Study start

Jul 1, 2026 Actual

Primary completion

Jul 1, 2027 Estimated

Study completion

Dec 31, 2027 Estimated

First posted

May 8, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts