Prevention of cerebral embolism related to carotid revascularisation Circulatory System
Conditions
Interventions
Observation (detection) of cerebral embolism, as depicted by diffusion-weighted magnetic resonance imaging, in consecutive patients with symptomatic or asymptomatic carotid stenosis undergoing transfe
Sponsors
Jagiellonian University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Clinical criteria 1. Consecutive patients 18-100 years old accepted for CAS following neurological consultation and qualification for the procedure according to international guidelines. 2. The target lesion is a "de novo" atherosclerotic lesion 3. More than 6 months of life expectancy 4. Suitable clinical conditions for performing DW-MRI 5. Written informed consent approved by the Ethics Committee 6. Subject agrees to all required follow-up procedures and visits Angiographic criteria 1. Symptomatic (transient ischemic attack, stroke, or amaurosis fugax within the last six months on the ipsilateral side of the stenosis) with carotid stenosis =50% as diagnosed by angiography using NASCET methodology, or 3. Asymptomatic patient with carotid stenosis =80% as diagnosed by angiography using NASCET methodology Procedural criteria 1. Procedure involves the use of proximal cerebral protection ("Tailored" consecutive-patient CAS) 2. Procedure involves use of micronet-covered stent(s) (consecutive patients) 3. Feasibility to perform cerebral MR (DW) imaging
Exclusion criteria
Exclusion criteria: Clinical 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 three times normal) 6. Female patients of childbearing potential or known to be pregnant 7. Any known factor for potential stroke other than carotid stenoses, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia 8. Patient on VKA or new oral anticoagulants 9. Patients with coagulopathies 10. Any known stroke with the primary cause other than carotid artery stenosis 11. History of severe disabling stroke according to the modified RANKIN scale > 4 12. Patient has an intracranial aneurysm or arteriovenous malformation 13. Chronic heart failure III-IV NYHA functional class 14. Chronic or decompensated right ventricular failure 15. Polyvalent drug allergy 16. Sharp infringement of cerebral circulation 17. Serious occlusive disease of the peripheral arteries, which could interfere with the intervention and installation of the introducer sheath 18. The main carotid artery disease is not atherosclerosis (for example, vasculitis, traumatic lesions, radiation stenosis, fibromuscular dysplasia) 19. States impeding the performance of MRI 20. Lack of consent Angiographic criteria 1. Total occlusion of the ipsilateral carotid artery 2. Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch 3. Severe lesion calcification restricting stent deployment 4. >50% stenosis of the CCA proximal to target vessel 5. Known mobile plaque in the aortic arch 6. Lesion length exceeding 30 mm
Countries
Poland
Contacts
Public ContactPiotr Musialek
Outcome results
None listed