Carotid Stenosis, Stroke
Conditions
Keywords
carotid stenting, embolism protection, Carotid Stenosis
Brief summary
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
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.
Interventions
DEVICEproximal embolism protection device
a proximal occlusion Mo.Ma will be used as the embolism protection device during CAS
DEVICEdistal embolism protection device
a distal SpiderFX will be used as the embolism protection device during CAS
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients 40 years of age and older. 2. Asymptomatic patients with internal carotid artery stenosis≥70% on angiography. 3. Symptomatic patients with internal carotid artery stenosis≥50% on angiography. 4. High-intensity Signal in the relevant plaques on the TOF-MRA. 5. Anatomic characteristics of the lesions that made it possible to use either type of embolism protective device (proximal or distal). 6. 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
1. Extensive ipsilateral or disabling stroke(mRS≥2). 2. Ischemic ipsilateral stroke in 15 days, with significant new ischemic lesions on the DWI image. 3. Ipsilateral intracranial artery stenosis which needs to be treated at the same time. 4. Extremely calcified aortic arc that compromised the origin of the common carotid artery or the brachiocephalic trunk. 5. Chronic or paroxysmal atrial fibrillation treated with oral anticoagulation. 6. Acute coronary syndrome in the 30-day period before the procedure. 7. Patient has a history of bleeding diathesis within 1 month or coagulopathy or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated. 8. Intolerance or allergic reaction to a study medication without a suitable management alternative. 9. Pregnant or lactating female patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ipsilateral new ischemic lesions on DWI | within 7 days post-operation | the incidence of ipsilateral new ischemic lesions on DWI after CAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| major stroke | within 7 days post-operation | 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 |
| myocardial infarction | within 7 days post-operation | 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 |
| death | within 7 days post-operation | In-hospital mortality |
| Other procedure-related complications | within 7 days post-operation | including major/minor hemorrhage, acute kidney injury, etc. |
| The number, size, and location of new cerebral ischemic lesions on DW-MRI | within 7 days post-operation | The number, size, and location of new cerebral ischemic lesions on DW-MRI |
Countries
China
Outcome results
None listed