Asymptomatic Patients (Stenosis =80%) Clinical Trial
— SIBERIA-2Official 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.
| Status | Recruiting |
| Enrollment | 366 |
| Est. completion date | January 1, 2027 |
| Est. primary completion date | November 1, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | E. Meshalkin National Medical Research Center | Novosibirsk |
| Lead Sponsor | Collaborator |
|---|---|
| Meshalkin Research Institute of Pathology of Circulation | Chelyabinsk Regional Clinical Hospital, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
Russian Federation,
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 P — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | determination of ischemic lesions | Postprocedural acute ischemic lesions (MRI) | 24-48 hours | |
| Secondary | MACCE | Death, stroke, and MI | Intraoperatively, and within 48 hours. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03488199 -
The SIBERIA Trial (Acculink™ Versus CGuard™)
|
N/A |