Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
---|---|
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00190398 |
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:
Condition | Intervention | Phase |
---|---|---|
Transient Ischemic Attack Carotid Stenosis Atherosclerosis |
Device: Carotid angioplasty and stenting with cerebral protection |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis |
Estimated Enrollment: | 900 |
Study Start Date: | November 2000 |
Estimated Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France, Ile De France | |
Sainte-Anne Hospital: Department of Neurology | |
PARIS, Ile De France, France, 75674 cedex14 |
Principal Investigator: | Jean-Louis MAS, Pr, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P990402, AOM97066 |
Study First Received: | September 14, 2005 |
Last Updated: | February 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00190398 |
Health Authority: | France: Ministry of Health |
Prospective Randomised Open |
Blinded End-point PROBE Study Ischemic stroke |
Pathological Conditions, Anatomical Atherosclerosis Arterial Occlusive Diseases Ischemic Attack, Transient Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Constriction, Pathologic Ischemia Arteriosclerosis Brain Diseases Cerebrovascular Disorders Carotid Stenosis Brain Ischemia Carotid Artery Diseases |
Nervous System Diseases Cardiovascular Diseases |