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

Primary Purpose

Stroke, Carotid Stenosis

Status

Withdrawn

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

proximal embolism protection device

distal embolism protection device

About this trial

This is an interventional treatment trial for Stroke focused on measuring carotid stenting, embolism protection, Carotid Stenosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Xuanwu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAS with proximal protection

CAS with distal protection

Arm Description

using proximal embolism protection device during CAS

using distal protection device during CAS

Outcomes

Primary Outcome Measures

ipsilateral new ischemic lesions on DWI

the incidence of ipsilateral new ischemic lesions on DWI after CAS

Secondary Outcome Measures

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

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

death

In-hospital mortality

Other procedure-related complications

including major/minor hemorrhage, acute kidney injury, etc.

The number, size, and location of new cerebral ischemic lesions on DW-MRI

Full Information

NCT ID

NCT04872127

First Posted

April 30, 2021

Last Updated

October 9, 2022

Sponsor

Xuanwu Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT04872127

Brief Title

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

Acronym

MOSCASH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Withdrawn

Why Stopped

device unavailable

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

May 1, 2023 (Anticipated)

Study Completion Date

February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Carotid Stenosis

Keywords

carotid stenting, embolism protection, Carotid Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAS with proximal protection

Arm Type

Experimental

Arm Description

using proximal embolism protection device during CAS

Arm Title

CAS with distal protection

Arm Type

Active Comparator

Arm Description

using distal protection device during CAS

Intervention Type

Device

Intervention Name(s)

proximal embolism protection device

Other Intervention Name(s)

Mo.Ma Ultra (Invatec/Medtronic Vascular Inc, Santa Rosa, California)

Intervention Description

a proximal occlusion Mo.Ma will be used as the embolism protection device during CAS

Intervention Type

Device

Intervention Name(s)

distal embolism protection device

Other Intervention Name(s)

SpiderFX (Medtronic, Minneapolis, Minnesota, USA)

Intervention Description

a distal SpiderFX will be used as the embolism protection device during CAS

Primary Outcome Measure Information:

Title

ipsilateral new ischemic lesions on DWI

Description

the incidence of ipsilateral new ischemic lesions on DWI after CAS

Time Frame

within 7 days post-operation

Secondary Outcome Measure Information:

Title

major stroke

Description

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

Time Frame

within 7 days post-operation

Title

myocardial infarction

Description

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

Time Frame

within 7 days post-operation

Title

death

Description

In-hospital mortality

Time Frame

within 7 days post-operation

Title

Other procedure-related complications

Description

including major/minor hemorrhage, acute kidney injury, etc.

Time Frame

within 7 days post-operation

Title

The number, size, and location of new cerebral ischemic lesions on DW-MRI

Description

The number, size, and location of new cerebral ischemic lesions on DW-MRI

Time Frame

within 7 days post-operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liqun Jiao, MD, PhD

Organizational Affiliation

Department of Neurosurgery & Interventional Neuroradiology Xuanwu Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xuanwu Hospital

City

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

21868725

Citation

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.

Results Reference

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PubMed Identifier

24262620

Citation

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.

Results Reference

background

PubMed Identifier

25125014

Citation

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.

Results Reference

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

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