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

Not Applicable

Withdrawn

• Conditions: Carotid Stenosis; Stroke
• Interventions: Device: distal embolism protection device; Device: proximal embolism protection device

• Registration Number: NCT04872127
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study Start: 2021-05-01
• Study First Posted: 2021-05-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-09
• Last Update Posted: 2022-10-12
• Primary Completion: 2023-05-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CAS with distal protection	distal embolism protection device	using distal protection device during CAS
CAS with proximal protection	proximal embolism protection device	using proximal embolism protection device during CAS

Primary Outcome Measures

Name	Time	Method
ipsilateral new ischemic lesions on DWI	within 7 days post-operation	the incidence of ipsilateral new ischemic lesions on DWI after CAS

Secondary Outcome Measures

Name	Time	Method
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
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
death	within 7 days post-operation	In-hospital mortality
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

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, China