StrokeMOSCASHNCT04872127
Distal Versus Proximal Protection on Cerebral Microembolization During High-risk Carotid Artery Stenting
A study testing proximal embolism protection device and distal embolism protection device in people with Stroke and Carotid Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke, Carotid Stenosis
- What is being tested?
- proximal embolism protection device and distal embolism protection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Feb 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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) .
Read the detailed description
CAS is an alternative to carotid endarterectomy(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 multicenter, prospective, outcome-assessor-blinded, randomized controlled trial study (MOSCASH) is designed to compare the efficiency of distal and proximal embolism protection devices during CAS procedure of patients with high-intensity signal in the plaque on the TOF-MRA. Asymptomatic patients with internal carotid artery stenosis ≥ 70% (NASCET) and symptomatic patients with a stenosis ≥ 50% who 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 proximal (Mo.Ma Ultra) protection. The primary endpoint is the incidence of new cerebral ipsilateral ischemic lesions on the Diffusion Weighted Imaging(DWI) in 7-days post operation. Secondary endpoints include the number, size, location of new cerebral ischemic lesions on the DWI, procedural complications, stroke, myocardial infarction, and death in 7 days.
- Conditions
- Stroke, Carotid Stenosis
- Being tested
- proximal embolism protection device, distal embolism protection device
- Keywords
- carotid stenting, embolism protection, Carotid Stenosis
- 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.
proximal embolism protection deviceDevice
Also called Mo.Ma Ultra (Invatec/Medtronic Vascular Inc, Santa Rosa, California)
a proximal occlusion Mo.Ma will be used as the embolism protection device during CAS
distal embolism protection deviceDevice
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 |
|---|---|---|
| CAS with proximal protection | Experimental | using proximal embolism protection device during CAS Receives: Device: proximal embolism protection device |
| CAS with distal protection | Active comparator | using distal protection device during CAS Receives: Device: distal embolism protection device |
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 (5)
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
Other procedure-related complications
including major/minor hemorrhage, acute kidney injury, etc.
Measured: within 7 days post-operation
The number, size, and location of new cerebral ischemic lesions on DW-MRI
The number, size, and location of new cerebral ischemic lesions on DW-MRI
Measured: within 7 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 May 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Why it stopped: device unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- 0 participants (actual)
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 Neurosurgery & Interventional Neuroradiology Xuanwu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872127
- Sponsor's protocol ID
- MOSCASH
- Acronym
- MOSCASH
- Status last verified
- Oct 2022
- First submitted
- 30 Apr 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data(IPD) that underlie results in a publication
Publications
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.
PubMed 21868725Cano 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.
PubMed 24262620Akkaya 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.
PubMed 25125014
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Versus Proximal Protection on Cerebral Microembolization During High-risk Carotid Artery Stenting
- ClinicalTrials.gov ID
- NCT04872127
- Acronym / sponsor ID
- MOSCASH / MOSCASH
- Conditions
- Stroke, Carotid Stenosis
- Keywords
- carotid stenting, embolism protection, Carotid Stenosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: device unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 4 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 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) .
Detailed description
CAS is an alternative to carotid endarterectomy(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 multicenter, prospective, outcome-assessor-blinded, randomized controlled trial study (MOSCASH) is designed to compare the efficiency of distal and proximal embolism protection devices during CAS procedure of patients with high-intensity signal in the plaque on the TOF-MRA. Asymptomatic patients with internal carotid artery stenosis ≥ 70% (NASCET) and symptomatic patients with a stenosis ≥ 50% who 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 proximal (Mo.Ma Ultra) protection. The primary endpoint is the incidence of new cerebral ipsilateral ischemic lesions on the Diffusion Weighted Imaging(DWI) in 7-days post operation. Secondary endpoints include the number, size, location of new cerebral ischemic lesions on the DWI, procedural complications, stroke, myocardial infarction, and death in 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAS with proximal protection | Experimental | Device: proximal embolism protection deviceusing proximal embolism protection device during CAS |
| CAS with distal protection | Active comparator | Device: distal embolism protection deviceusing distal protection device during CAS |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| proximal embolism protection deviceAlso: Mo.Ma Ultra (Invatec/Medtronic Vascular Inc, Santa Rosa, California)a proximal occlusion Mo.Ma will be used as the embolism protection device during CAS | Device | CAS with proximal protection |
| distal embolism protection deviceAlso: SpiderFX (Medtronic, Minneapolis, Minnesota, USA)a distal SpiderFX will be used as the embolism protection device during CAS | Device | CAS with distal protection |
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
5 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
Other procedure-related complications
Time frame: within 7 days post-operation
The number, size, and location of new cerebral ischemic lesions on DW-MRI
Time frame: within 7 days post-operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Background: PubMed 21868725Yoshimura 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.
- Background: PubMed 24262620Cano 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.
- Background: PubMed 25125014Akkaya 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.
- Individual participant dataSharing planned: Yes. all individual participant data(IPD) that underlie results in a publication
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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 Neurosurgery & Interventional Neuroradiology Xuanwu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proximal embolism protection device and distal embolism protection device 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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 12 Oct 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT04872127, which also lists 3 linked publications.
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 12 Oct 2022.