StrokeCASH-ESNCT04904250
Spider Versus Emboshield Distal Protection on Cerebral Microembolization During Vulnerable Plaque in Carotid Artery Stenting
A study testing Emboshield and Spider in people with Stroke and Carotid Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Carotid Stenosis, Carotid Artery Stent
- What is being tested?
- Emboshield and Spider
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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..
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital
Beijing
Yanfei Chen, MD, +8613701285010, chenyanflying@126.com
Lin Yan, MD, +8615601204926, yanlin19910926@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Carotid Stenosis, Carotid Artery Stent
- Being tested
- Emboshield, Spider
- Keywords
- stroke, carotid stenosis, carotid artery stenting
- Medical subject headings
- Stroke, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmboshieldDevice
Also called Emboshield NAV6 (Abbott vascular, Santa Clara, CA, USA)
a distall occlusion Emboshield NAV6 will be used as the embolism protection device during CAS
SpiderDevice
Also called SpiderFX (Medtronic, Minneapolis, Minnesota, USA)
a distal SpiderFX will be used as the embolism protection device during CAS
| Study group | Role | What they receive |
|---|---|---|
| Emboshield NAV6 | Experimental | using Emboshield NAV6 distal embolism protection device during CAS Receives: Device: Emboshield |
| SpiderFX | Active comparator | using SpiderFX distal protection device during CAS Receives: Device: Spider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral new ischemic lesions on DWI
The incidence of ipsilateral new ischemic lesions on DWI after CAS
Measured: Within 7 days post-operation
Secondary outcomes (8)
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
Measured: 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
Measured: within 7 days post-operation
death
In-hospital mortality
Measured: within 7 days post-operation
Any hemorrhage, acute kidney injury and other procedure-related complications
including major/minor hemorrhage, acute kidney injury, etc.
Measured: 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
Measured: 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
Measured: 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
Measured: within 7 days post-operation
MES counting during CAS
TCD monitoring of MES counting during CAS
Measured: during CAS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start27 Aug 2022 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liqun Jiao, MD, PhD, Principal investigator, Department of Interventional Neuroradiology, Department of Neurosurgery, International Neuroscience Institute (China-INI), Xuanwu Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904250
- Sponsor's protocol ID
- CASH-ES
- Acronym
- CASH-ES
- Status last verified
- Jun 2022
- First submitted
- 30 Apr 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan L, Shu L, Xinyi S, Zhang N, Lu Y, Feng Y, Wang Y, Gao P, Ma Y, Chen J, Yang B, Feng Y, Chen Y, Jiao L. Two different distal protections on cerebral microembolization of vulnerable plaque during carotid artery stenting (CASH-ES): study protocol for a randomized controlled trial. Trials. 2026 Apr 18;27(1):401. doi: 10.1186/s13063-026-09687-3.
PubMed 42001098
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpiderFX Versus Emboshield Nav6 Distal Protection on Cerebral Microembolization in Vulnerable Plaque During Carotid Artery Stenting
- ClinicalTrials.gov ID
- NCT04904250
- Acronym / sponsor ID
- CASH-ES / CASH-ES
- Conditions
- Stroke, Carotid Stenosis, Carotid Artery Stent
- Keywords
- stroke, carotid stenosis, carotid artery stenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 27 Aug 2022 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emboshield NAV6 | Experimental | Device: Emboshieldusing Emboshield NAV6 distal embolism protection device during CAS |
| SpiderFX | Active comparator | Device: Spiderusing SpiderFX distal protection device during CAS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmboshieldAlso: Emboshield NAV6 (Abbott vascular, Santa Clara, CA, USA)a distall occlusion Emboshield NAV6 will be used as the embolism protection device during CAS | Device | Emboshield NAV6 |
| SpiderAlso: SpiderFX (Medtronic, Minneapolis, Minnesota, USA)a distal SpiderFX will be used as the embolism protection device during CAS | Device | SpiderFX |
Primary outcome
Ipsilateral new ischemic lesions on DWI
Time frame: Within 7 days post-operation
The incidence of ipsilateral new ischemic lesions on DWI after CAS
8 secondary outcomes
major stroke
Time frame: within 7 days post-operation
myocardial infarction
Time frame: within 7 days post-operation
death
Time frame: within 7 days post-operation
Any hemorrhage, acute kidney injury and other procedure-related complications
Time frame: within 7 days post-operation
The number of new cerebral ischemic lesions on DW-MRI
Time frame: within 7 days post-operation
The size of new cerebral ischemic lesions on DW-MRI
Time frame: within 7 days post-operation
The location of new cerebral ischemic lesions on DW-MRI
Time frame: within 7 days post-operation
MES counting during CAS
Time frame: during CAS procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 42001098Yan L, Shu L, Xinyi S, Zhang N, Lu Y, Feng Y, Wang Y, Gao P, Ma Y, Chen J, Yang B, Feng Y, Chen Y, Jiao L. Two different distal protections on cerebral microembolization of vulnerable plaque during carotid artery stenting (CASH-ES): study protocol for a randomized controlled trial. Trials. 2026 Apr 18;27(1):401. doi: 10.1186/s13063-026-09687-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liqun Jiao, MD, PhD principal investigator
Department of Interventional Neuroradiology, Department of Neurosurgery, International Neuroscience Institute (China-INI), Xuanwu Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emboshield and Spider in people with Stroke and Carotid Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanfei Chen, MD (+8613701285010, chenyanflying@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral new ischemic lesions on DWI (time frame: Within 7 days post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.