NCT07054060 Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2
| NCT ID | NCT07054060 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier St Anne |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2028-03-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-07-16 with a primary completion date of 2028-03-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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
Contact & Investigator
David Calvet, Professor
STUDY DIRECTOR
GHU Sainte-Anne, PARIS
Frequently Asked Questions
Who can join the NCT07054060 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07054060 currently recruiting?
Yes, NCT07054060 is actively recruiting participants. Contact the research team at d.calvet@ghu-paris.fr for enrollment information.
Where is the NCT07054060 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07054060 clinical trial?
NCT07054060 is sponsored by Centre Hospitalier St Anne. The principal investigator is David Calvet, Professor at GHU Sainte-Anne, PARIS. The trial plans to enroll 600 participants.
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