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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto de Investigación Marqués de Valdecilla

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Symptomatic or asymptomatic carotid artery stenosis

Candidate for carotid artery stenting

Written informed consent provided

Disqualifiers

Vascular anatomy unsuitable for balloon guide catheter placement

Severe renal failure

Previous disabling stroke or symptomatic intracranial hemorrhage

Evidence of carotid thrombus

Trial design

Design model

Parallel

Treatments tested in this trial

  • balloon guide catheter

    Device

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

  • No Proximal Protection Group

    Other intervention

    Carotid artery stenting without proximal embolic protection

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: carotid artery stenting with proximal embolic protection using a balloon guide catheterExperimental treatment 1 intervention
Group B: ratio to carotid artery stenting without proximal embolic protection using a balloon guide catheter.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Incidence of myocardial infarction or death within 30 days

Time frame
30days
3

Technical success of carotid artery stenting procedure

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.

Time frame
30days
4

Correlation between DW-MRI findings and clinical outcomes

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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