Carotid Artery Stenting Without Protection

Study Overview
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Brief Summary
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A recent randomized Carotid artery stenting (CAS) trial in which carotid protection device (CPD)s were used to demonstrate equivalence with carotid endarterectomy (CEA) by achieving noninferiority regarding periprocedural risk. However, the clinical efficacy and safety of CPDs are still a matter of controversy. It has been argued that the limited reduction provided by CPDs may be due to the devices themselves. Probably, they serve as sources for emboli during the procedure or removal technique. In general, 30- day adverse outcome for CAS with the use of CPDs seems not to be different from the outcome without CPDs. Thus, the main goal in this study is to test the hypothesis that CAS without CPD usage is as safe as in those patients who undergo CAS with CPD neuroprotection.

Detailed Description
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The Carotid Artery Stenting without Embolic Protection (CASWEP) trial is designed in a prospective, randomized, multi-center fashion to determine if CAS without CPD is feasible and safe in patients with symptomatic or asymptomatic severe carotid stenosis. Study participants After the exclusion criterias were applied 279 patients were divided as 139 patients in the CAS with CPD arm and 140 patients in the CAS without CPD arm. Our study population includes patients with severe carotid artery stenosis referred to the 3 study center hospitals.

Official Title
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Carotid Artery Stenting Without Embolic Protection: A Randomized Multicenter Trial (the CASWEP Trial)

Conditions
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Carotid Arteries

Intervention / Treatment
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* Device: CAS with CPD
* Other: CAS without CPD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic patients with ≥ 50% ipsilateral carotid stenosis by angiography, ≥70% by duplex ultrasound, or ≥70% by Computerized tomography (CT) angiography or Magnetic Resonance (MR) angiography if the stenosis on ultrasonography was 50% to 69%. Asymptomatic patients with ≥60% stenosis by angiography, ≥70% by ultrasound, or ≥80% by CT angiography or MR angiography if the stenosis on ultrasonography was 50% to 69%. Exclusion Criteria: Total occlusion, Visible thrombus at the lesion site Bleeding diathesis Cerebral vascular malformation, Degenerative cerebral diseases Cerebral tumors Illness impeding informed consent Life expectancy<2 years Previous CEA.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CAS with CPD<br>CAS performed under neuroprotection | Device: CAS with CPD<br>* using a neuroprotection device<br>|
| Active Comparator: CAS without CPD<br>CAS without neuroprotection | Other: CAS without CPD<br>* No Neuroprotection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients experiencing new ischemic brain lesions on diffusion-weighted magnetic resonance imaging (DWMRI), transient ischemic attack (TIA), Stroke and death events. | peri-procedural in hospital outcome | through hospital admission, an average of 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stenting, Protection device, EPD usage