Clinical trial NCT03488199: The SIBERIA Trial (Acculink™ Versus CGuard™)
Official title: Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Aterosclerotic Carotid Stenosis
Symptomatic Patients (Stenosis > 50%)
Asymptomatic Patients (Stenosis ≥80%)
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2018-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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).

Eligibility criteria: Inclusion Criteria

1. Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
2. More than 6-month life expectancy
3. Suitable clinical conditions for performing DW-MRI
4. Written Informed consent approved by the Ethics Committee
5. Subject agrees to all required follow-up procedures and visits

Exclusion Criteria:

1. Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
2. Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
3. Hepatic active disease (bilirubin\> 35 mmol / l) or renal insufficiency (serum creatinine \> 2.5 mg/dL or glomerular filtration rate \<60 ml / min)
4. Recent evolving acute stroke within 30-days of study evaluation
5. Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB \> 3 times normal)
6. Female patients of childbearing potential or known to be pregnant
7. Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia
8. Patient on VKA or new oral anticoagulants

Primary outcomes:
measure: determination of ischemic lesions
timeFrame: at 30-days
measure: determination of ischemic lesions
timeFrame: at 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Andrey A. Karpenko
Study officials:
References:
citation: 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.