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NCT07576790Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 8 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
126 (estimated)
First submitted
26 Mar 2026
Start date
1 Jul 2026
Primary completion date
1 Jul 2027
Lead sponsor
Instituto de Investigación Marqués de Valdecilla
Diseases
Stroke
NCT number
NCT07576790

What you commit to

  • Study type: Interventional
  • Planned participants: 126
  • From 1 Jul 2026 to the primary completion date, 1 Jul 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous disabling stroke or symptomatic intracranial hemorrhage
  • Contraindications to anticoagulant or antiplatelet therapy
  • Lack of prior dual antiplatelet therapy

Other illness

  • Severe renal failure
  • Acute coronary syndrome within 30 days
  • Contrast media allergy

Other

  • Vascular anatomy unsuitable for balloon guide catheter placement
  • Evidence of carotid thrombus
  • Severe common carotid artery lesion
  • Chronic atrial fibrillation on oral anticoagulation
  • Contraindications to MRI

Who the study is looking for

  • Age ≥ 18 years
  • Symptomatic or asymptomatic carotid artery stenosis
  • Candidate for carotid artery stenting
  • Written informed consent provided

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.