Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: balloon guide catheter, No Proximal Protection Group.
- Who it may be relevant to
- Registry conditions: Carotid Artery Stenosis (Symptomatic and Asymptomatic). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting: A Randomized Study (EMBO-PROTECT)
Overview
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.
Interventions
- Device balloon guide catheter
Carotid artery stenting with proximal embolic protection using a balloon guide catheter. - Other No Proximal Protection Group
Carotid artery stenting without proximal embolic protection
Primary outcome measures
- 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 outcome measures (4)
- 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]
- Correlation between DW-MRI findings and clinical outcomes [Time frame: 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07576790 · EMBO-PROTECT · NEXTVAL