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

NCT04872127 | Withdrawn

• 1 other identifier: MOSCASH
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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) .

Conditions

Stroke; Carotid Stenosis

Keywords

carotid stenting; embolism protection; Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• ipsilateral new ischemic lesions on DWI

  the incidence of ipsilateral new ischemic lesions on DWI after CAS

  within 7 days post-operation

Secondary Outcomes (5)

• major stroke

  within 7 days post-operation

• myocardial infarction

  within 7 days post-operation

• death

  within 7 days post-operation

• Other procedure-related complications

  within 7 days post-operation

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

  within 7 days post-operation

Study Arms (2)

CAS with proximal protection

EXPERIMENTAL

using proximal embolism protection device during CAS

Device: proximal embolism protection device

CAS with distal protection

ACTIVE COMPARATOR

using distal protection device during CAS

Device: distal embolism protection device

Interventions

proximal embolism protection device DEVICE

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

Also known as: Mo.Ma Ultra (Invatec/Medtronic Vascular Inc, Santa Rosa, California)

CAS with proximal protection

distal embolism protection device DEVICE

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

Also known as: SpiderFX (Medtronic, Minneapolis, Minnesota, USA)

CAS with distal protection

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

Location

Related Publications (3)

• 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.

  PMID: 21868725 BACKGROUND

• 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.

  PMID: 24262620 BACKGROUND

• 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.

  PMID: 25125014 BACKGROUND

MeSH Terms

Conditions

Stroke; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Arterial Occlusive Diseases

Study Officials

• Liqun Jiao, MD, PhD

  Department of Neurosurgery & Interventional Neuroradiology Xuanwu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 4, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: February 1, 2024
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: To share IPD in the magazine of paper published.

Locations

CN (1)