NCT00190398

EVA3S: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether carotid angioplasty with stent (CAS) is as safe and effective as carotid surgery in regards to: 1. the risk of stroke and death within 30 days of the procedure; 2. the long-term risk of ipsilateral carotid territory stroke, in patients with recently symptomatic, severe carotid stenosis suitable for both CAS and carotid endarterectomy.

Detailed description

Findings from two large randomized clinical trials - NASCET and ECST - have established endarterectomy as the standard treatment for severe symptomatic carotid artery stenosis. Compared to endarterectomy, stenting with or without cerebral protection has the advantage of avoiding general anesthesia and incision in the neck that could lead to nerve injury and wound complications. The costs may be less than those of surgery, mainly because of a shorter hospital stay. However, stenting also carries a risk of stroke and local complications. Unlike endarterectomy, which has known long-term benefits, stenting does not remove the atheromatous plaque, and the long-term efficacy of this technique needs also to be assessed. Several trials are in progress in Europe and the United States. We established this trial to evaluate whether stenting is not inferior to endarterectomy concerning (a) the risk of stroke or death within 30 days of procedure and (b) the long-term risk of ipsilateral stroke, in patients with recently symptomatic, severe carotid stenosis.

Conditions

• Transient Ischemic Attack
• Carotid Stenosis
• Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Carotid angioplasty and stenting with cerebral protection	Carotid angioplasty and stenting with cerebral protection

Timeline

• Start date: 2000-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2005-09-19
• Last updated: 2011-05-02

Locations

1 site across 1 country: France