Carotid Artery Stenosis (Symptomatic and Asymptomatic)
Conditions
Keywords
Carotid stenosis, Carotid artery stenting, Balloon guide catheter, Proximal embolic protection, Cerebral microembolism, Diffusion-weighted MRI, Stroke prevention
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.
Interventions
DEVICEballoon guide catheter
Carotid artery stenting with proximal embolic protection using a balloon guide catheter.
OTHERNo Proximal Protection Group
Carotid artery stenting without proximal embolic protection
Sponsors
Instituto de Investigación Marqués de Valdecilla
Study design
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.
Intervention model description
Participants are randomly assigned in a 1:1 ratio to carotid artery stenting with or without proximal embolic protection using a balloon guide catheter.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, number, and volume of new cerebral ischemic lesions detected by diffusion-weighted MRI within 48 hours after carotid artery stenting | Within 48 hours after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of symptomatic thromboembolic events (stroke or transient ischemic attack) within 30 days | During the procedure and within 30 days after the intervention | — |
| Incidence of myocardial infarction or death within 30 days | 30days | — |
| Technical success of carotid artery stenting procedure | 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 | 30 days | — |
Contacts
CONTACTveronica vidal
CONTACTlucia lavin
Outcome results
None listed