NCT07576790

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

March 26, 2026

Last Update Submit

May 4, 2026

Conditions

Carotid Artery Stenosis (Symptomatic and Asymptomatic)

Keywords

Carotid stenosisCarotid artery stentingBalloon guide catheterProximal embolic protectionCerebral microembolismDiffusion-weighted MRIStroke prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Correlation between DW-MRI findings and clinical outcomes

    30 days

Study Arms (2)

carotid artery stenting with proximal embolic protection using a balloon guide catheter

EXPERIMENTAL
Device: balloon guide catheter

ratio to carotid artery stenting without proximal embolic protection using a balloon guide catheter.

ACTIVE COMPARATOR
Other: No Proximal Protection Group

Interventions

balloon guide catheterDEVICE

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

carotid artery stenting with proximal embolic protection using a balloon guide catheter
No Proximal Protection GroupOTHER

Carotid artery stenting without proximal embolic protection

ratio to carotid artery stenting without proximal embolic protection using a balloon guide catheter.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

veronica vidal

CONTACT

942203389veronica.vidal@idival.org

lucia lavin

CONTACT

lucia.lavin@idival.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in a 1:1 ratio to carotid artery stenting with or without proximal embolic protection using a balloon guide catheter.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2026

First Posted

May 8, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05