Spider Versus Emboshield Distal Protection on Cerebral Microembolization During Vulnerable Plaque in Carotid Artery Stenting

NCT04904250 | Unknown

• 1 other identifier: CASH-ES
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, prospective, outcome-assessor-blinded, randomized controlled trial study (CASH-ES) is designed to compare the efficiency of two different distal embolism protection devices (SpiderFX and Emboshield NAV6) in during CAS procedure of patients with vulnerable plaque.

Conditions

Stroke; Carotid Stenosis; Carotid Artery Stent

Keywords

stroke; carotid stenosis; carotid artery stenting

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 (8)

• major stroke

  within 7 days post-operation

• myocardial infarction

  within 7 days post-operation

• death

  within 7 days post-operation

• Any hemorrhage, acute kidney injury and other procedure-related complications

  within 7 days post-operation

• The number of new cerebral ischemic lesions on DW-MRI

  within 7 days post-operation

Study Arms (2)

Emboshield NAV6

EXPERIMENTAL

using Emboshield NAV6 distal embolism protection device during CAS

Device: Emboshield

SpiderFX

ACTIVE COMPARATOR

using SpiderFX distal protection device during CAS

Device: Spider

Interventions

Emboshield DEVICE

a distall occlusion Emboshield NAV6 will be used as the embolism protection device during CAS

Also known as: Emboshield NAV6 (Abbott vascular, Santa Clara, CA, USA)

Emboshield NAV6

Spider DEVICE

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

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

SpiderFX

Eligibility Criteria

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

You may qualify if:

• Male and female patients 18 years of age and older.
• Symptomatic patients with internal carotid artery stenosis≥50% on angiography, or asymptomatic patients with internal carotid artery stenosis≥70% on angiography.
• Anatomic characteristics of the lesions that made it possible to use either type of distal embolism protective device (Emboshield or Spider).
• The lesion was located in the internal carotid artery (ICA) or the bifurcation of the carotid artery.
• Only one WALLSTENT is expected to treat target lesions.
• Tolerance to aspirin/clopidogrel/heparin and other drug therapy.
• 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.
• High-intensity Signal in the relevant plaques on the TOF-MRA.

You may not qualify if:

• Extensive ipsilateral or disabling stroke(mRS≥2) or cerebrovascular events occurred within 1 month combined with neurological defects.
• Myocardial infarction occurred within 72 hours or TIA within 48 hours.
• Atrial fibrillation (chronic or paroxysmal) is not treated with anticoagulation.
• Ipsilateral intracranial artery stenosis with a history of stenting.
• CABG or vascular surgery in the 30-day period before the procedure.
• Acute coronary syndrome in the 30-day period before the procedure.
• Life span within 12 months.
• 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.
• The femoral artery condition is not good enough to enter the guidewire or the sound window is not good enough to conduct intraoperative TCD monitoring of the patient.
• Unfavorable femoral artery anatomy for endovascular intervention or unfavorable acoustic window for intraoperative TCD monitoring.
• WBC\<3\*109/L, PLT\<50\*109/L or \>700\*109/L.
• Pregnant or lactating female patient.
• DSA indicated the target vessel occlusion; The tandem lesions could not be covered by one stent; The target vessel was seriously tortuous or the internal carotid artery was not suitable for WallStent; The aortic arch has severe calcification or tortuosity involving the common carotid artery or brachial trunk; Combined with cerebral AVM or cerebral aneurysms which need treatment; Carotid artery stenosis not caused by atherosclerosis, but arteritis, arterial dissection, congenital malformation of blood vessels, or severe vascular lesions after radiotherapy, etc..

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

Location

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 Interventional Neuroradiology, Department of Neurosurgery, International Neuroscience Institute (China-INI), Xuanwu Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanfei Chen, MD

CONTACT

+8613701285010; chenyanflying@126.com

Lin Yan, MD

CONTACT

+8615601204926; yanlin19910926@163.com

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 27, 2021
• Study Start: August 27, 2022
• Primary Completion: May 31, 2024
• Study Completion: October 1, 2024
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)