NCT03488199CompletedNot Applicable
Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial
Meshalkin Research Institute of Pathology of Circulation1 site in 1 country100 target enrollmentStarted: September 11, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- determination of ischemic lesions
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
- •More than 6-month life expectancy
- •Suitable clinical conditions for performing DW-MRI
- •Written Informed consent approved by the Ethics Committee
- •Subject agrees to all required follow-up procedures and visits
Exclusion Criteria
- •Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
- •Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
- •Hepatic active disease (bilirubin> 35 mmol / l) or renal insufficiency (serum creatinine > 2.5 mg/dL or glomerular filtration rate <60 ml / min)
- •Recent evolving acute stroke within 30-days of study evaluation
- •Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB > 3 times normal)
- •Female patients of childbearing potential or known to be pregnant
- •Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia
- •Patient on VKA or new oral anticoagulants
Outcomes
Primary Outcomes
determination of ischemic lesions
Time Frame: at 48 hours
New DW-MRI lesions post procedural (48 hours)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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