Spider Versus Emboshield Distal Protection on Cerebral Microembolization During Vulnerable Plaque in Carotid Artery Stenting (CASH-ES)
Primary Purpose
Stroke, Carotid Stenosis, Carotid Artery Stent
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Emboshield
Spider
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, carotid stenosis, carotid artery stenting
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- With Intracranial tumor and is not considered suitable for inclusion or could not complete the MRI examination.
- 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..
Sites / Locations
- Xuanwu Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Emboshield NAV6
SpiderFX
Arm Description
using Emboshield NAV6 distal embolism protection device during CAS
using SpiderFX 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
Any hemorrhage, acute kidney injury and other procedure-related complications
including major/minor hemorrhage, acute kidney injury, etc.
The number of new cerebral ischemic lesions on DW-MRI
The number of new cerebral ischemic lesions on DW-MRI
The size of new cerebral ischemic lesions on DW-MRI
The size of new cerebral ischemic lesions on DW-MRI
The location of new cerebral ischemic lesions on DW-MRI
The location of new cerebral ischemic lesions on DW-MRI
MES counting during CAS
TCD monitoring of MES counting during CAS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04904250
Brief Title
Spider Versus Emboshield Distal Protection on Cerebral Microembolization During Vulnerable Plaque in Carotid Artery Stenting
Acronym
CASH-ES
Official Title
SpiderFX Versus Emboshield Nav6 Distal Protection on Cerebral Microembolization in Vulnerable Plaque During Carotid Artery Stenting
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 27, 2022 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
October 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Carotid Stenosis, Carotid Artery Stent
Keywords
stroke, carotid stenosis, carotid artery stenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Emboshield NAV6
Arm Type
Experimental
Arm Description
using Emboshield NAV6 distal embolism protection device during CAS
Arm Title
SpiderFX
Arm Type
Active Comparator
Arm Description
using SpiderFX distal protection device during CAS
Intervention Type
Device
Intervention Name(s)
Emboshield
Other Intervention Name(s)
Emboshield NAV6 (Abbott vascular, Santa Clara, CA, USA)
Intervention Description
a distall occlusion Emboshield NAV6 will be used as the embolism protection device during CAS
Intervention Type
Device
Intervention Name(s)
Spider
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
Any hemorrhage, acute kidney injury and other procedure-related complications
Description
including major/minor hemorrhage, acute kidney injury, etc.
Time Frame
within 7 days post-operation
Title
The number of new cerebral ischemic lesions on DW-MRI
Description
The number of new cerebral ischemic lesions on DW-MRI
Time Frame
within 7 days post-operation
Title
The size of new cerebral ischemic lesions on DW-MRI
Description
The size of new cerebral ischemic lesions on DW-MRI
Time Frame
within 7 days post-operation
Title
The location of new cerebral ischemic lesions on DW-MRI
Description
The location of new cerebral ischemic lesions on DW-MRI
Time Frame
within 7 days post-operation
Title
MES counting during CAS
Description
TCD monitoring of MES counting during CAS
Time Frame
during CAS procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
With Intracranial tumor and is not considered suitable for inclusion or could not complete the MRI examination.
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..
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanfei Chen, MD
Phone
+8613701285010
Email
chenyanflying@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Yan, MD
Phone
+8615601204926
Email
yanlin19910926@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao, MD, PhD
Organizational Affiliation
Department of Interventional Neuroradiology, Department of Neurosurgery, International Neuroscience Institute (China-INI), Xuanwu Hospital, Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanfei Chen, MD
Phone
+8613701285010
Email
chenyanflying@126.com
First Name & Middle Initial & Last Name & Degree
Lin Yan, MD
Phone
+8615601204926
Email
yanlin19910926@163.com
First Name & Middle Initial & Last Name & Degree
Liqun Jiao, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Spider Versus Emboshield Distal Protection on Cerebral Microembolization During Vulnerable Plaque in Carotid Artery Stenting
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