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

May 4, 2026 updated by: Instituto de Investigación Marqués de Valdecilla

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: carotid artery stenting with proximal embolic protection using a balloon guide catheter
Device: balloon guide catheter
Carotid artery stenting with proximal embolic protection using a balloon guide catheter.
Active Comparator: ratio to carotid artery stenting without proximal embolic protection using a balloon guide catheter.
Other: No Proximal Protection Group
Carotid artery stenting without proximal embolic protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 48 hours after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the procedure and within 30 days after the intervention
Incidence of myocardial infarction or death within 30 days
Time Frame: 30days
30days
Technical success of carotid artery stenting procedure
Time Frame: 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.
30days
Correlation between DW-MRI findings and clinical outcomes
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Marqués de Valdecilla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMBO-PROTECT
  • NEXTVAL (Other Grant/Funding Number: IDIVAL)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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