Patients With Aterosclerotic Carotid StenosisCASNCT03488199
The SIBERIA Trial (Acculink™ Versus CGuard™)
A study testing Stent Acculink ™ and CGuardTM™ 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
That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards 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?
- Stent Acculink ™ and CGuardTM™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 11 Sep 2017to 9 Mar 2021
- 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 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.
About this study
Official title: Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial
That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards
Read the detailed description
Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) was performed.
Ischemic lesions of brain after CAS were determined by MRI before and after treatment (2-3 days, 1 month).
- Conditions
- Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)
- Being tested
- Stent Acculink ™, CGuardTM™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent Acculink ™Device
Also called RX ACCULINK CAROTID STENT SYSTEM
Carotid Artery Revascularization using Stents
CGuardTM™Device
Also called The CGuardTM Embolic Prevention System (EPS)
Carotid Artery Revascularization using Stents
| Study group | Role | What they receive |
|---|---|---|
| Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM) | Active comparator | 50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM) Receives: Device: Stent Acculink ™ |
| Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS)) | Experimental | 50 Carotid stenting (The CGuardTM Embolic Prevention System (EPS)) Receives: Device: CGuardTM™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of ischemic lesions
New DW-MRI lesions post procedural their permanence at 30-days
Measured: at 30-days
determination of ischemic lesions
New DW-MRI lesions post procedural (48 hours)
Measured: at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start11 Sep 2017
- Primary completion11 Feb 2021
- Study completion9 Mar 2021
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488199
- Sponsor's protocol ID
- NRICP 9872
- Acronym
- CAS
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2017
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karpenko A, Bugurov S, Ignatenko P, Starodubtsev V, Popova I, Malinowski K, Musialek P. Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization. JACC Cardiovasc Interv. 2021 Nov 8;14(21):2377-2387. doi: 10.1016/j.jcin.2021.08.005.
PubMed 34736737
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial
- ClinicalTrials.gov ID
- NCT03488199
- Acronym / sponsor ID
- CAS / NRICP 9872
- Conditions
- Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 4 Apr 2018 (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.
That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards
Detailed description
Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) was performed.
Ischemic lesions of brain after CAS were determined by MRI before and after treatment (2-3 days, 1 month).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM) | Active comparator | Device: Stent Acculink ™50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM) |
| Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS)) | Experimental | Device: CGuardTM™50 Carotid stenting (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 |
|---|---|---|
| Stent Acculink ™Also: RX ACCULINK CAROTID STENT SYSTEMCarotid Artery Revascularization using Stents | Device | Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM) |
| CGuardTM™Also: The CGuardTM Embolic Prevention System (EPS)Carotid Artery Revascularization using Stents | Device | Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS)) |
Primary outcome
determination of ischemic lesions
Time frame: at 30-days
New DW-MRI lesions post procedural their permanence at 30-days
determination of ischemic lesions
Time frame: at 48 hours
New DW-MRI lesions post procedural (48 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 34736737Karpenko A, Bugurov S, Ignatenko P, Starodubtsev V, Popova I, Malinowski K, Musialek P. Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization. JACC Cardiovasc Interv. 2021 Nov 8;14(21):2377-2387. doi: 10.1016/j.jcin.2021.08.005.
Related trials for Patients With Aterosclerotic Carotid Stenosis
Recruiting
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent Acculink ™ and CGuardTM™ 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: finished, as of the sponsor's last update on 8 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
determination of ischemic lesions (time frame: at 30-days). The study lists 2 primary outcomes in all. 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 NCT03488199, 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 8 Oct 2021.