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StrokeEVA3S-2NCT07054060

Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2

A study testing carotid endarterectomy and Carotid artery stenting in people with Stroke, run by Centre Hospitalier St Anne at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Carotid stenosis caused by atherosclerosis is a significant risk factor for ischemic stroke, accounting for up to 15% of all strokes and transient ischemic attacks. Randomized clinical trials (RCTs) have demonstrated the benefits of carotid endarterectomy (CEA) in reducing stroke risk in patients with severe… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
carotid endarterectomy and Carotid artery stenting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteFrance
Study dates
16 Jul 2025to 16 Mar 2028
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

  • Patient age 18 years or over
  • Hemispheric or retinal transient ischemic attack or a non-disabling stroke (or retinal infarct) within 15 days before enrolment
  • Stenosis of 50% to 99% in the symptomatic carotid artery (NASCET method) for whom revascularisation is decided according to guidelines

Who cannot join

  • Patients unwilling or unable to participate in follow-up for whatever reason
  • Preexisting disability (Modified Rankin Score ≥ 3)
  • Nonatherosclerotic carotid disease
  • Severe tandem lesions
  • Previous revascularization of the symptomatic carotid stenosis
  • History of bleeding disorder
Show all 12Show fewer
  • Unstable angina
  • Contraindication to dual antiplatelet therapy
  • Contraindication to MRI
  • Life expectancy of less than 2 years
  • Percutaneaous or surgical intervention within 30 days before or after the study procedure
  • Stenotic lesion on arterial workup appeared as not a factor in the selection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Calvet, Professor contact

+33145658634

d.calvet@ghu-paris.fr

DRCI DRCI contact

info-recherche@ghu-paris.fr

France1 site, 1 recruiting

  • Centre hospitalier Sainte-Anne

    Paris, 75014

    David Calvet, d.calvet@ghu-paris.fr

    Recruiting

Other trials in France

About this study

Carotid stenosis caused by atherosclerosis is a significant risk factor for ischemic stroke, accounting for up to 15% of all strokes and transient ischemic attacks. Randomized clinical trials (RCTs) have demonstrated the benefits of carotid endarterectomy (CEA) in reducing stroke risk in patients with severe symptomatic carotid stenosis. Carotid artery stenting (CAS) has been developed as an alternative to CEA, offering several potential advantages, such as avoiding local surgical complications. However, unlike CEA, CAS has not been compared to medical therapy in RCTs for symptomatic carotid stenosis.

Read the detailed description

CEA vs CAS Comparison:

Early RCTs conducted in the 2000s showed that CAS was associated with a higher risk of procedural stroke or death compared to CEA (8.9% vs 5.8%; RR 1.53, 95% CI 1.20-1.96, p=0.0006). However, CAS was found to be as effective as CEA in preventing recurrent ipsilateral strokes up to 10 years after treatment. Interestingly, an ancillary study of the ICSS trial showed that significantly more patients in the CAS group (50%) than in the CEA group (17%) had new ischemic lesions on diffusion-weighted MRI (DWI), suggesting that DWI might serve as a surrogate outcome measure for future carotid intervention trials.

Data Analysis and Recent Advances:

Individual pooled data analysis of RCTs indicated that CAS could be as safe and effective as CEA in patients under 70 years old. Recent advances in CAS technology, stenting techniques, antiplatelet therapy, and pre-treatment imaging have improved the periprocedural safety of CAS. Due to its ability to treat patients soon after a stroke, CAS has become increasingly used in routine clinical practice.

Study Objectives:

The question remains whether CAS is as safe as CEA in patients with recent symptomatic severe carotid stenosis. The study's objectives are:

Primary Objective:

To assess whether carotid stenting is non-inferior to carotid endarterectomy in preventing new ischemic lesions on DWI MRI, confirmed by a core lab.

  • To assess the difference between groups regarding post-intervention MRI characteristics in terms of ischemic lesion number and size, vessel occlusion and hemorrhagic transformation
  • To assess differences between groups with regard to the procedural risks and efficacy (within 30 days after procedure) of
  1. any stroke or death
  2. any stroke,
  3. disabling or fatal stroke
  4. death
  5. transient ischemic attack
  6. myocardial infarction
  7. local complication
  8. cranial nerve palsy
Conditions
Stroke
Being tested
carotid endarterectomy, Carotid artery stenting
Keywords
CEA, CAS, stroke, Magnetic resonance imaging, Carotid Artery Stenting, Carotid Endarterectomy
Medical subject headings
Stroke, Apraxias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carotid endarterectomyProcedure or surgery

    Carotid endarterectomy is a surgical procedure used to reduce the risk of stroke due to carotid artery stenosis. During an endarterectomy, the surgeon opens the artery and removes the plaque.

  • Carotid artery stentingProcedure or surgery

    Carotid artery stenting is an endovascular procedure in which a stent is deployed in the lumen of the carotid artery to treat narrowing of the carotid artery and reduce the risk of stroke.

Study groups in NCT07054060
Study groupRoleWhat they receive
surgical armActive comparatorcarotid endarterectomy
Receives: Procedure: carotid endarterectomy
Stenting armActive comparatorCarotid artery stenting
Receives: Procedure: Carotid artery stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DWI Lesion Detection Rate

    Imaging endpoint : Proportion of patients having at least one new lesion on post-treatment Diffusion-Weigthed Imaging (DWI) MRI compared to pre-treatment DWI MRI and confirmed by a core lab.

    The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.

    Measured: From 3 days before procedure to 7 days after procedure

Secondary outcomes (15)

  1. Profile of lesions

    Imaging endpoint : Number and size of new lesions on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.

    Measured: From 3 days before procedure to 7 days after procedure

  2. Vessel Occlusion Profile

    Imaging endpoint : Proportion of patients having a new intracranial vessel occlusion on post-treatment MRI.

    The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.

    Measured: From 3 days before procedure to 7 days after procedure

  3. Hemorrhage

    Imaging endpoint : Hemorrhagic transformation on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.

    Measured: From 3 days before procedure to 7 days after procedure

  4. Stroke/Mortality

    Clinical endpoint : proportion of patients having any stroke or death during periprocedural period.

    Measured: From randomization to 30 days after procedure

  5. Stroke Incidence Rate

    Clinical endpoint : Proportion of patients having any stroke during periprocedural period.

    Measured: From randomization to 30 days after procedure

  6. Severe Stroke Incidence

    Clinical endpoint : Proportion of patients having any disabling or fatal stroke during periprocedural period.

    Measured: From randomization to 30 days after procedure

  7. Mortality

    Clinical endpoint : Proportion of patients who died during periprocedural period.

    Measured: From randomization to 30 days after procedure

  8. TIA Incidence

    Clinical endpoint : Proportion of patients having a Transient ischemic attack during periprocedural period.

    Measured: From randomization to 30 days after procedure

  9. MI Occurrence

    Clinical endpoint : Proportion of patients having myocardial infarction during periprocedural period.

    Measured: From randomization to 30 days after procedure

  10. Local complication

    Clinical endpoint : cervical or groin or radial hematoma, infection, arteriovenous fistula at puncture site, lower-limb arterial occlusion during periprocedural period.

    Measured: From randomization to 30 days after procedure

  11. Cranial Nerve Injury Events

    Clinical endpoint : Proportion of patients having cranial nerve injury during periprocedural period.

    Measured: From randomization to 30 days after procedure

  12. Hospitalization Duration

    Healthcare endpoint : number of days the patient stayed in the hospital stay

    Measured: From the date of the carotid artery stenting (CAS) or endarterectomy (CEA) procedure until the date of hospital discharge, assessed up to 30 days

  13. Procedure Delay

    Operational endpoint: number of days between the date at which the patient is randomized and the date at which the carotid artery stenting (CAS) or endarterectomy) is proceeded

    Measured: From the date of patient randomization until the date of carotid artery stenting (CAS) or endarterectomy (CEA) procedure, assessed up to 15 days

  14. Ischemic Events

    Clinical endpoint: Incidence of ischemic events among patients with confirmed new lesions on post-procedure DWI MRI (as verified by core lab assessment). The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.

    Measured: From 3 days before procedure to 7 days after procedure.

  15. Hemorrhage

    Imaging endpoint : Hemorrhagic transformation on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.

    Measured: From 3 days before procedure to 7 days after procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start16 Jul 2025
  3. Primary completion16 Mar 2028 (estimated)
  4. Study completion16 Mar 2028 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07054060
Sponsor's protocol ID
D24-P001
Other IDs
PHRC-22-0121, 2024-A01377-40
Acronym
EVA3S-2
Status last verified
Jul 2025
First submitted
13 May 2025
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

Questions about this trial

What is this clinical trial studying?

A study testing carotid endarterectomy and Carotid artery stenting in people with Stroke, run by Centre Hospitalier St Anne at 1 site in France.

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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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 David Calvet, Professor (+33145658634, d.calvet@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DWI Lesion Detection Rate (time frame: From 3 days before procedure to 7 days after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07054060.

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 24 Jul 2025.

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