Status:
WITHDRAWN
Distal Versus Proximal Protection on Cerebral Microembolization During High-risk Carotid Artery Stenting
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Stroke
Carotid Stenosis
Eligibility:
All Genders
40+ years
Phase:
NA
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 caroti...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04872127
Start Date
May 1 2021
End Date
February 1 2024
Last Update
October 12 2022
Active Locations (1)
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1
Xuanwu Hospital
Beijing, China