Distal Versus Proximal Protection on Cerebral Microembolization During High-risk Carotid Artery Stenting

Study Overview
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Brief Summary
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A multicenter, prospective, outcome-assessor-blinded, randomized controlled trial study (MOSCASH) is designed to compare the efficiency of distal and proximal embolism protection devices during carotid angioplasty and stenting (CAS) procedure of patients with high-intensity signal in the plaque on the time-of-flight magnetic resonance angiography(TOF-MRA) .

Detailed Description
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CAS is an alternative to carotid endarterectomy(CEA) for treating carotid stenosis with a similar efficacy in preventing future stroke. High-intensity signal in the plaque on the TOF-MRA is associated to a high risk of cerebral embolism during stenting. The evidence of protection selection in such patients was limited. A multicenter, prospective, outcome-assessor-blinded, randomized controlled trial study (MOSCASH) is designed to compare the efficiency of distal and proximal embolism protection devices during CAS procedure of patients with high-intensity signal in the plaque on the TOF-MRA. Asymptomatic patients with internal carotid artery stenosis ≥ 70% (NASCET) and symptomatic patients with a stenosis ≥ 50% who have a high-intensity signal in the relevant plaques on TOF-MRA will be included. Patients are randomized in two balanced groups (1:1) to receive CAS with either distal (Spider FX) or proximal (Mo.Ma Ultra) protection. The primary endpoint is the incidence of new cerebral ipsilateral ischemic lesions on the Diffusion Weighted Imaging(DWI) in 7-days post operation. Secondary endpoints include the number, size, location of new cerebral ischemic lesions on the DWI, procedural complications, stroke, myocardial infarction, and death in 7 days.

Official Title
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Distal Versus Proximal Protection on Cerebral Microembolization During High-risk Carotid Artery Stenting

Conditions
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Stroke, Carotid Stenosis

Intervention / Treatment
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* Device: proximal embolism protection device
* Device: distal embolism protection device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients 40 years of age and older. Asymptomatic patients with internal carotid artery stenosis≥70% on angiography. Symptomatic patients with internal carotid artery stenosis≥50% on angiography. High-intensity Signal in the relevant plaques on the TOF-MRA. Anatomic characteristics of the lesions that made it possible to use either type of embolism protective device (proximal or distal). The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Medical Ethics Committee, Institutional Review Board, or Human Research Ethics Committee. Exclusion Criteria: Extensive ipsilateral or disabling stroke(mRS≥2). Ischemic ipsilateral stroke in 15 days, with significant new ischemic lesions on the DWI image. Ipsilateral intracranial artery stenosis which needs to be treated at the same time. Extremely calcified aortic arc that compromised the origin of the common carotid artery or the brachiocephalic trunk. Chronic or paroxysmal atrial fibrillation treated with oral anticoagulation. Acute coronary syndrome in the 30-day period before the procedure. Patient has a history of bleeding diathesis within 1 month or coagulopathy or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated. Intolerance or allergic reaction to a study medication without a suitable management alternative. Pregnant or lactating female patient.

Ages Eligible for Study
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Minimum Age: 40 Years

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: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAS with proximal protection<br>using proximal embolism protection device during CAS | Device: proximal embolism protection device<br>* a proximal occlusion Mo.Ma will be used as the embolism protection device during CAS<br>* Other names: Mo.Ma Ultra (Invatec/Medtronic Vascular Inc, Santa Rosa, California);|
| Active Comparator: CAS with distal protection<br>using distal protection device during CAS | Device: distal embolism protection device<br>* a distal SpiderFX will be used as the embolism protection device during CAS<br>* Other names: SpiderFX (Medtronic, Minneapolis, Minnesota, USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ipsilateral new ischemic lesions on DWI | the incidence of ipsilateral new ischemic lesions on DWI after CAS | within 7 days post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major stroke | the incidence of major stroke after CAS, defined as new onset of neurological symptoms causing an increase of NIHSS ≥ 4 or worsening of existing focal neurological deficit lasting ≥ 24 hours | within 7 days post-operation | 
| myocardial infarction | the incidence of myocardial infarction after CAS, defined as new onset of chest discomfort or cardiac stroke or heart failure with a rise and/or fall of cardiac biomarkers and ECG abnormalities | within 7 days post-operation | 
| death | In-hospital mortality | within 7 days post-operation | 
| Other procedure-related complications | including major/minor hemorrhage, acute kidney injury, etc. | within 7 days post-operation | 
| The number, size, and location of new cerebral ischemic lesions on DW-MRI | The number, size, and location of new cerebral ischemic lesions on DW-MRI | within 7 days post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid stenting, embolism protection, Carotid Stenosis