IMaging Della PLAcca Carotidea "IMPLAC"


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- bearing an asymptomatic carotid stenosis of 30-70% in diameter, as established by Doppler-measured peak systolic flow velocity, according to the Society of Radiologists in Ultrasound Consensus Conference (Grant et al. Radiology 2003).

Exclusion Criteria

- pregnancy or possibility of pregnancy,
- history of allergic diathesis,
- history of stroke or transitory ischemic attack,
- previous carotid artery stenting or carotid endarterectomy,
- history of autoimmune vasculitis,
- History of drug abuse, alcohol abuse or any psychiatric or social condition which may contraindicate the participation to a clinical study
- life expectancy of less than 18 months due to underlying medical conditions,
- presence of cognitive impairment preventing the patient from providing informed consent,
- Atrial fibrillation or previous cardiac surgery or positioning of intracardiac devices (excluded coronary stents) as potential confounding causes of cerebral ischemic damage,
- Known patent foramen ovale (PFO) necessitating anti-platelet treatment
- Current anti-coagulation,
- Previous infections to the central nervous system (CNS)
- Previous surgery to the CNS
- History of anoxic damage to the CNS
- Dementia
- Contraindications to computed tomography angiography (CTA, estimated Glomerular Filtration Rate<60 mL/min; history of allergic reaction to iodinated contrast media),
- Specific contraindication to MRI:
- Claustrophobia
- Sickle cell anemia
- Systemic mastocytosis
- Implanted cardiac devices (i.e. pacemakers, implantable cardioverter defibrillators)
- Vascular clips
- Vertebral distractors
- Infusion pumps
- Neurostimulators
- Liquor derivations
- Any device which could be dispositioned in the presence of a strong magnetic field