Patients With Aterosclerotic Carotid StenosisSIBERIA-2NCT05257161
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
A study testing Emboshield NAV6™ and Mo.Ma™ in people with Patients With Aterosclerotic Carotid Stenosis and Symptomatic Patients (Stenosis > 50%), run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)
- What is being tested?
- Emboshield NAV6™ and Mo.Ma™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2021to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
- More than 6-month life expectancy
- Suitable clinical conditions for performing DW-MRI
- Written Informed consent approved by the Ethics Committee
- Subject agrees to all required follow-up procedures and visits
Who cannot join
- Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
- Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
- Hepatic active disease (bilirubin> 35 mmol / l) or renal insufficiency (serum creatinine > 2.5 mg/dL or glomerular filtration rate <60 ml / min)
- Recent evolving acute stroke within 30-days of study evaluation
- Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB > 3 times normal)
- Female patients of childbearing potential or known to be pregnant
- Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia
- Patient on VKA or new oral anticoagulants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
E. Meshalkin National Medical Research Center
Novosibirsk
Andrey A Karpenko, MD, a_karpenko@meshalkin.ru
About this study
Official title: Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS
The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent.
- Conditions
- Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)
- Being tested
- Emboshield NAV6™, Mo.Ma™
- Keywords
- Carotid artery stenting. CGuard stent. Protection Device.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emboshield NAV6™Device
Also called Emboshield NAV6™ Embolic Protection System
Embolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™
Mo.Ma™Device
Also called Mo.Ma™ proximal cerebral protection device
Embolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™
| Study group | Role | What they receive |
|---|---|---|
| Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS)) | Active comparator | 183 Carotid stenting (Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS)) Receives: Device: Emboshield NAV6™ |
| MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS) | Experimental | 183 Carotid stenting (MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)) Receives: Device: Mo.Ma™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of ischemic lesions
Postprocedural acute ischemic lesions (MRI)
Measured: 24-48 hours
Secondary outcomes (1)
MACCE
Death, stroke, and MI
Measured: Intraoperatively, and within 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (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 Patients With Aterosclerotic Carotid StenosisStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Collaborators
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, Chelyabinsk Regional Clinical Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257161
- Sponsor's protocol ID
- SIBERIA 2
- Acronym
- SIBERIA-2
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.
PubMed 32007460
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS
- ClinicalTrials.gov ID
- NCT05257161
- Acronym / sponsor ID
- SIBERIA-2 / SIBERIA 2
- Conditions
- Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)
- Keywords
- Carotid artery stenting. CGuard stent. Protection Device.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Collaborators
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, Chelyabinsk Regional Clinical Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Feb 2022 (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.
The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS)) | Active comparator | Device: Emboshield NAV6™183 Carotid stenting (Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS)) |
| MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS) | Experimental | Device: Mo.Ma™183 Carotid stenting (MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS)) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
- More than 6-month life expectancy
- Suitable clinical conditions for performing DW-MRI
- Written Informed consent approved by the Ethics Committee
- Subject agrees to all required follow-up procedures and visits
Key exclusion criteria (8 listed)
- Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
- Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
- Hepatic active disease (bilirubin> 35 mmol / l) or renal insufficiency (serum creatinine > 2.5 mg/dL or glomerular filtration rate <60 ml / min)
- Recent evolving acute stroke within 30-days of study evaluation
- Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB > 3 times normal)
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 |
|---|---|---|
| Emboshield NAV6™Also: Emboshield NAV6™ Embolic Protection SystemEmbolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™ | Device | Emboshield NAV6™ Embolic Protection System + CGuard™ (The CGuardTM Embolic Prevention System (EPS)) |
| Mo.Ma™Also: Mo.Ma™ proximal cerebral protection deviceEmbolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™ | Device | MO.MA Proximal Cerebral Protection Device+ CGuard™ (The CGuardTM Embolic Prevention System (EPS) |
Primary outcome
determination of ischemic lesions
Time frame: 24-48 hours
Postprocedural acute ischemic lesions (MRI)
1 secondary outcome
MACCE
Time frame: Intraoperatively, and within 48 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Results publication: PubMed 32007460Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.
- Related InfoLink provided by the sponsor.
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.
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 NAV6™ and Mo.Ma™ in people with Patients With Aterosclerotic Carotid Stenosis and Symptomatic Patients (Stenosis > 50%), run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Feb 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 Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrey A Kaprenko, MD (+79139504100, a_karpenko@meshalkin.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of ischemic lesions (time frame: 24-48 hours). 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 NCT05257161, 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 25 Feb 2022.