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

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

Treatments tested in this trial

  • balloon guide catheter
  • No Proximal Protection Group

Treatment groups

126 Participants
are divided into 2 treatment groups

Locations

This trial has no locations