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NCT Number: NCT07576790

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

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.

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Key information

Conditions

Carotid Artery Stenosis (Symptomatic and Asymptomatic) Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

balloon guide catheter

Device

Carotid artery stenting with proximal embolic protection using a balloon guide catheter.

No Proximal Protection Group

Other

Carotid artery stenting without proximal embolic protection

Primary outcomes

Incidence, number, and volume of new cerebral ischemic lesions detected by diffusion-weighted MRI within 48 hours after carotid artery stenting

Time frame: Within 48 hours after the procedure

Secondary outcomes

Incidence of symptomatic thromboembolic events (stroke or transient ischemic attack) within 30 days

Time frame: During the procedure and within 30 days after the intervention
Incidence of myocardial infarction or death within 30 days

Time frame: 30days
Technical success of carotid artery stenting procedure

Time frame: 30days

Technical success defined as successful deployment of the stent with residual stenosis <30% and restoration of adequate blood flow without the need for conversion to another technique.
Correlation between DW-MRI findings and clinical outcomes

Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

lucia lavin

CONTACT

[email protected]

veronica vidal

CONTACT

[email protected]

942203389

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Marqués de Valdecilla

Other

Registry information

Official study title

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

Acronym: EMBO-PROTECT

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 8, 2026
Registry last updated: May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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