Stenting versus surgical plaque removal for recent severe carotid artery narrowing
Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT07054060 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris
- Centre hospitalier Sainte-Anne — Paris, France (Recruiting)
Study contacts
- Study coordinator: David Calvet, Professor
- Email: d.calvet@ghu-paris.fr
- Phone: +33145658634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.