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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM) | Active Comparator | 50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM) |
|
| Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS)) | Experimental | 50 Carotid stenting (The CGuardTM Embolic Prevention System (EPS)) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent Acculink ™ | Device | Carotid Artery Revascularization using Stents |
|
| Measure | Description | Time Frame |
|---|---|---|
| determination of ischemic lesions | New DW-MRI lesions post procedural their permanence at 30-days | at 30-days |
| determination of ischemic lesions | New DW-MRI lesions post procedural (48 hours) | at 48 hours |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrey A. Karpenko | Novosibirsk | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34736737 | Derived | 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. |
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| CGuardTM™ | Device | Carotid Artery Revascularization using Stents |
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