Asymptomatic Patients (Stenosis ≥80%), Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%)
Conditions
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).
Interventions
DEVICECGuardTM™
Carotid Artery Revascularization using Stents
DEVICEStent Acculink ™
Carotid Artery Revascularization using Stents
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| determination of ischemic lesions | at 30-days | New DW-MRI lesions post procedural their permanence at 30-days |
Countries
Russia
Outcome results
None listed