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

Stroke Clinical Trial

— MOSCASH  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04872127
• Other study ID #: MOSCASH
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: October 2022
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Stenosis
• Stroke

Intervention

Device:
• proximal embolism protection device
a proximal occlusion Mo.Ma will be used as the embolism protection device during CAS
• distal embolism protection device
a distal SpiderFX will be used as the embolism protection device during CAS

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

Cano MN, Kambara AM, de Cano SJ, Pezzi Portela LA, Paes ÂT, 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ipsilateral new ischemic lesions on DWI	the incidence of ipsilateral new ischemic lesions on DWI after CAS	within 7 days post-operation
Secondary	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
Secondary	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
Secondary	death	In-hospital mortality	within 7 days post-operation
Secondary	Other procedure-related complications	including major/minor hemorrhage, acute kidney injury, etc.	within 7 days post-operation
Secondary	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