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

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) .

Study Overview

• Status: Withdrawn
• Conditions: Stroke; Carotid Stenosis
• Intervention / Treatment: Device: proximal embolism protection device; Device: distal embolism protection device

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Liqun Jiao, MD, PhD, Department of Neurosurgery & Interventional Neuroradiology Xuanwu Hospital

Publications and helpful links

General Publications

• Yoshimura S, Yamada K, Kawasaki M, Asano T, Kanematsu M, Takamatsu M, Hara A, Iwama T. High-intensity signal on time-of-flight magnetic resonance angiography indicates carotid plaques at high risk for cerebral embolism during stenting. Stroke. 2011 Nov;42(11):3132-7. doi: 10.1161/STROKEAHA.111.615708. Epub 2011 Aug 25.
• Cano MN, Kambara AM, de Cano SJ, Pezzi Portela LA, Paes AT, Costa JR Jr, Abizaid AA, Moreira SM, Sousa AG, Sousa JE. Randomized comparison of distal and proximal cerebral protection during carotid artery stenting. JACC Cardiovasc Interv. 2013 Nov;6(11):1203-9. doi: 10.1016/j.jcin.2013.07.006.
• Akkaya E, Vuruskan E, Gul ZB, Yildirim A, Pusuroglu H, Surgit O, Kalkan AK, Akgul O, Akgul GP, Gul M. Cerebral microemboli and neurocognitive change after carotid artery stenting with different embolic protection devices. Int J Cardiol. 2014 Sep 20;176(2):478-83. doi: 10.1016/j.ijcard.2014.07.241. Epub 2014 Aug 12.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Carotid Stenosis; carotid stenting; embolism protection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: MOSCASH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all individual participant data(IPD) that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: To share IPD in the magazine of paper published.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No