Atherosclerosis, Carotid Stenosis, Transient Ischemic Attack
Conditions
Keywords
Prospective, Randomised, Open, Blinded End-point, PROBE Study, Ischemic stroke
Brief 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.
Interventions
DEVICECarotid angioplasty and stenting with cerebral protection
Carotid angioplasty and stenting with cerebral protection
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* In brief, patients are eligible if they have experienced a carotid TIA or non disabling stroke within 4 months before randomisation and if they have an atherosclerotic stenosis of the region of the ipsilateral carotid bifurcation of 60% or more, as determined by the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method, that investigators believe is suitable for both carotid endarterectomy and endovascular treatment. The degree of stenosis warranting treatment initially set at 70% or more was subsequently set at 60% or greater to reflect current generally accepted practice in the treatment of symptomatic carotid stenosis. The presence of a 60% or more ipsilateral carotid stenosis has to be confirmed by conventional digital subtraction angiography or the combination of carotid Duplex scanning and magnetic resonance angiography, provided the results of these non-invasive techniques are concordant.
Exclusion criteria
* Patients cannot be included if they have a disabling stroke (mRS \>=3), a non atherosclerotic carotid disease, a severe intracranial carotid artery stenosis, contra-indications to heparin, ticlopidine or clopidogrel. * There is no age limit. * The presence of contralateral occlusion and/or the angiographic appearance of the stenotic lesion are not factors in treatment selection. The randomisation algorithm takes centre and degree of stenosis (more or less than 90% stenosis) into account. Patients must be treated as soon as possible after random assignment, in any case within 2 weeks of randomisation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any stroke or death within 30 days of the procedure | during de study | Any stroke or death within 30 days of the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical: Myocardial infarction within 30 days of the procedure | during the study | Clinical: Myocardial infarction within 30 days of the procedure |
| Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA]) | during the study | Other complications within 30 days of the procedure: cerebral (transient ischemic attack \[TIA\]) |
| locoregional (e.g. cranial nerve palsy, complications at the site of puncture) | during the study | locoregional (e.g. cranial nerve palsy, complications at the site of puncture) |
| General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period | during the study | General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period |
| Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period | during the study | Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period |
| TIA during the follow-up period | during the study | TIA during the follow-up period |
| Functional status at the end of the study | during the study | Functional status at the end of the study |
| Anatomical: Carotid restenosis (> 70% on carotid ultrasound) | during the study | Anatomical: Carotid restenosis (\> 70% on carotid ultrasound) |
| Integrity of the stent 2 years after the procedure (on cervical radiogram) | during the study | Integrity of the stent 2 years after the procedure (on cervical radiogram) |
Countries
France
Outcome results
None listed