Carotid Artery Stenosis (Symptomatic and Asymptomatic)EMBO-PROTECTNCT07576790
Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)
A study testing balloon guide catheter and No Proximal Protection Group in people with Carotid Artery Stenosis (Symptomatic and Asymptomatic), run by Instituto de Investigación Marqués de Valdecilla.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis (Symptomatic and Asymptomatic)
- What is being tested?
- balloon guide catheter and No Proximal Protection Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Symptomatic or asymptomatic carotid artery stenosis
- Candidate for carotid artery stenting
- Written informed consent provided
Who cannot join
- 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
Show all 11Show fewer
- Acute coronary syndrome within 30 days
- Contraindications to anticoagulant or antiplatelet therapy
- Contraindications to MRI
- Contrast media allergy
- Lack of prior dual antiplatelet therapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
lucia lavin contact
About this study
Official title: 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.
- Being tested
- balloon guide catheter, No Proximal Protection Group
- Keywords
- Carotid stenosis, Carotid artery stenting, Balloon guide catheter, Proximal embolic protection, Cerebral microembolism, Diffusion-weighted MRI, Stroke prevention
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon guide catheterDevice
Carotid artery stenting with proximal embolic protection using a balloon guide catheter.
No Proximal Protection GroupOther
Carotid artery stenting without proximal embolic protection
| Study group | Role | What they receive |
|---|---|---|
| carotid artery stenting with proximal embolic protection using a balloon guide catheter | Experimental | Not described Receives: Device: balloon guide catheter |
| ratio to carotid artery stenting without proximal embolic protection using a balloon guide catheter. | Active comparator | Not described Receives: Other: No Proximal Protection Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, number, and volume of new cerebral ischemic lesions detected by diffusion-weighted MRI within 48 hours after carotid artery stenting
Measured: Within 48 hours after the procedure
Secondary outcomes (4)
Incidence of symptomatic thromboembolic events (stroke or transient ischemic attack) within 30 days
Measured: During the procedure and within 30 days after the intervention
Incidence of myocardial infarction or death within 30 days
Measured: 30days
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.
Measured: 30days
Correlation between DW-MRI findings and clinical outcomes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery Stenosis (Symptomatic and Asymptomatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to carotid artery stenting with or without proximal embolic protection using a balloon guide catheter.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576790
- Sponsor's protocol ID
- EMBO-PROTECT
- Other IDs
- NEXTVAL
- Acronym
- EMBO-PROTECT
- Status last verified
- May 2026
- First submitted
- 26 Mar 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting: A Randomized Study (EMBO-PROTECT)
- ClinicalTrials.gov ID
- NCT07576790
- Acronym / sponsor ID
- EMBO-PROTECT / EMBO-PROTECT
- Keywords
- Carotid stenosis, Carotid artery stenting, Balloon guide catheter, Proximal embolic protection, Cerebral microembolism, Diffusion-weighted MRI, Stroke prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to carotid artery stenting with or without proximal embolic protection using a balloon guide catheter.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Symptomatic or asymptomatic carotid artery stenosis
- Candidate for carotid artery stenting
- Written informed consent provided
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balloon guide catheterCarotid artery stenting with proximal embolic protection using a balloon guide catheter. | Device | carotid artery stenting with proximal embolic protection using a balloon guide catheter |
| No Proximal Protection GroupCarotid artery stenting without proximal embolic protection | Other | ratio to carotid artery stenting without proximal embolic protection using a balloon guide catheter. |
Primary outcome
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
4 secondary outcomes
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
Incidence of myocardial infarction or death within 30 days
Time frame: 30days
Technical success of carotid artery stenting procedure
Time frame: 30days
Correlation between DW-MRI findings and clinical outcomes
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
lucia lavin contact
Questions about this trial
What is this clinical trial studying?
A study testing balloon guide catheter and No Proximal Protection Group in people with Carotid Artery Stenosis (Symptomatic and Asymptomatic), run by Instituto de Investigación Marqués de Valdecilla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact veronica vidal (942203389, veronica.vidal@idival.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.