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| Name | Class |
|---|---|
| Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | OTHER |
| Chelyabinsk Regional Clinical Hospital | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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)) |
|
| 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)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emboshield NAV6™ | Device | Embolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™ |
|
| Measure | Description | Time Frame |
|---|---|---|
| determination of ischemic lesions | Postprocedural acute ischemic lesions (MRI) | 24-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | Death, stroke, and MI | Intraoperatively, and within 48 hours. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrey A Kaprenko, MD | Contact | +79139504100 | a_karpenko@meshalkin.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E. Meshalkin National Medical Research Center | Recruiting | Novosibirsk | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32007460 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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|
| Mo.Ma™ | Device | Embolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™ |
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