Stenting versus surgical plaque removal for recent severe carotid artery narrowing
Official title: Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2
Run by Centre Hospitalier St Anne · NCT07054060 · Data updated 2026-11-12
This trial will test whether carotid artery stenting works as well as carotid endarterectomy at preventing new small brain ischemic lesions in adults who recently had symptoms from severe carotid narrowing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | July 16, 2025 |
| Main results expected | March 16, 2028 |
| Study ends | March 16, 2028 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT07054060 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who had a hemispheric or retinal TIA or a non-disabling stroke within the past 15 days and have 50–99% symptomatic carotid stenosis (NASCET method) and are judged eligible for revascularization.
✕Probably not a fit
Patients with prior revascularization of the symptomatic carotid, nonatherosclerotic carotid disease, severe tandem lesions, contraindications to MRI or dual antiplatelet therapy, significant preexisting disability (mRS ≥3), bleeding disorders, or life expectancy under two years are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with a recent hemispheric or retinal transient ischemic attack or a non-disabling stroke and 50–99% symptomatic carotid stenosis are randomized to carotid endarterectomy (CEA) or carotid artery stenting (CAS). The primary outcome is new ischemic lesions on diffusion-weighted MRI (DWI), with images reviewed by a central core lab. The trial enrolls patients within 15 days of the qualifying event and applies standard exclusions such as contraindications to MRI or dual antiplatelet therapy. The design reflects prior randomized comparisons and incorporates modern stenting techniques and imaging to compare periprocedural brain injury between the two approaches.
Why it matters
Potential benefit: If stenting is non-inferior, patients could have a less invasive treatment option that provides similar protection from recurrent brain ischemia and often allows faster recovery.
How similar studies have gone: Earlier randomized trials showed higher short-term procedural stroke risk with stenting but similar long-term prevention of ipsilateral stroke, and pooled analyses plus recent technological and procedural advances suggest improved safety of CAS in selected patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where it's running
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Centre hospitalier Sainte-Anne
Paris, France Recruiting
Study contacts
- Study coordinator: David Calvet, Professor
- Email: d.calvet@ghu-paris.fr
- Phone: +33145658634
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.