Spider Versus Emboshield Distal Protection on Cerebral Microembolization During Vulnerable Plaque in Carotid Artery Stenting (CASH-ES)

SpiderFX Versus Emboshield Nav6 Distal Protection on Cerebral Microembolization in Vulnerable Plaque During Carotid Artery Stenting

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Carotid Stenosis; Carotid Artery Stent
• Intervention / Treatment: Device: Emboshield; Device: Spider

Detailed Description

CAS is an alternative to 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 single center, prospective, outcome- assessor-blinded, randomized controlled trial study (CASH-ES) is designed to compare the efficiency of two distal embolism protection devices (SpiderFX and Emboshield NAV6) during CAS procedure of patients with vulnerable plaque. Asymptomatic patients with internal carotid artery stenosis ≥ 70% (NASCET) and symptomatic patients with a stenosis ≥ 50% who is over 70 years old, diagnostic of vulnerable plaque on ultrasound or 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 distal (Emboshield NAV6) protection. The primary endpoint is the incidence of new cerebral ipsilateral ischemic lesions on the DW-MRI within 7-days post operation. Secondary endpoints include the number, size, location of new cerebral ischemic lesions on the DW-MRI, the counts of MES during TCCD monitoring during procedure, procedural complications, stroke, myocardial infarction, and death within 7 days.

• Study Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanfei Chen, MD; Phone Number: +8613701285010; Email: chenyanflying@126.com
• Study Contact Backup: Name: Lin Yan, MD; Phone Number: +8615601204926; Email: yanlin19910926@163.com

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital
    • Contact: Yanfei Chen, MD; Phone Number: +8613701285010; Email: chenyanflying@126.com
    • Contact: Lin Yan, MD; Phone Number: +8615601204926; Email: yanlin19910926@163.com
    • Principal Investigator: Liqun Jiao, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female patients 18 years of age and older.
2. Symptomatic patients with internal carotid artery stenosis≥50% on angiography, or asymptomatic patients with internal carotid artery stenosis≥70% on angiography.
3. Anatomic characteristics of the lesions that made it possible to use either type of distal embolism protective device (Emboshield or Spider).
4. The lesion was located in the internal carotid artery (ICA) or the bifurcation of the carotid artery.
5. Only one WALLSTENT is expected to treat target lesions.
6. Tolerance to aspirin/clopidogrel/heparin and other drug therapy.
7. 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.
8. High-intensity Signal in the relevant plaques on the TOF-MRA.

Exclusion Criteria:

1. Extensive ipsilateral or disabling stroke(mRS≥2) or cerebrovascular events occurred within 1 month combined with neurological defects.
2. Myocardial infarction occurred within 72 hours or TIA within 48 hours.
3. Atrial fibrillation (chronic or paroxysmal) is not treated with anticoagulation.
4. Ipsilateral intracranial artery stenosis with a history of stenting.
5. CABG or vascular surgery in the 30-day period before the procedure.
6. Acute coronary syndrome in the 30-day period before the procedure.
7. Life span within 12 months.
8. Patient has a history of bleeding diathesis within 1 month or coagulopathy or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated.
9. Intolerance or allergic reaction to a study medication without a suitable management alternative.
10. 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.
11. Unfavorable femoral artery anatomy for endovascular intervention or unfavorable acoustic window for intraoperative TCD monitoring.
12. With Intracranial tumor and is not considered suitable for inclusion or could not complete the MRI examination.
13. WBC<3*109/L, PLT<50*109/L or >700*109/L.
14. Pregnant or lactating female patient.
15. 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..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Emboshield NAV6; using Emboshield NAV6 distal embolism protection device during CAS	Device: Emboshield; a distall occlusion Emboshield NAV6 will be used as the embolism protection device during CAS; Other Names: Emboshield NAV6 (Abbott vascular, Santa Clara, CA, USA)
ACTIVE_COMPARATOR: SpiderFX; using SpiderFX distal protection device during CAS	Device: Spider; 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
Any hemorrhage, acute kidney injury and other procedure-related complications	including major/minor hemorrhage, acute kidney injury, etc.	within 7 days post-operation
The number of new cerebral ischemic lesions on DW-MRI	The number of new cerebral ischemic lesions on DW-MRI	within 7 days post-operation
The size of new cerebral ischemic lesions on DW-MRI	The size of new cerebral ischemic lesions on DW-MRI	within 7 days post-operation
The location of new cerebral ischemic lesions on DW-MRI	The location of new cerebral ischemic lesions on DW-MRI	within 7 days post-operation
MES counting during CAS	TCD monitoring of MES counting during CAS	during CAS procedure

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Liqun Jiao, MD, PhD, Department of Interventional Neuroradiology, Department of Neurosurgery, International Neuroscience Institute (China-INI), Xuanwu Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 27, 2022
• Primary Completion (ANTICIPATED): May 31, 2024
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (ACTUAL): May 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: stroke; carotid stenosis; carotid artery stenting
• 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: CASH-ES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No