Estenose de artéria carótida Atherosclerosis of other arteries
Conditions
Interventions
This is a contemporary cohort study (observational) in which up to 231 patients undergoing stent angioplasty for the treatment of atherosclerotic carotid artery stenosis will be enrolled. In these pat
Sponsors
Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Eligibility
Inclusion criteria
Inclusion criteria: Patient with a prior indication, before the study, for carotid artery stenting by any technique, scheduled to be performed within the next 30 days; age 18 years or older; any gender; diagnosis of carotid stenosis, from the mid terminal portion of the common carotid artery to the C2 segment of the internal carotid artery, whether symptomatic or asymptomatic; willing to receive telephone or virtual follow up contact for up to 90 days after treatment for clinical outcome assessment
Exclusion criteria
Exclusion criteria: Underlying non atherosclerotic carotid pathology; retreatment of a previously treated carotid artery, with a stent already implanted over the atheroma of the artery being evaluated; planned intervention for contralateral carotid pathology or planned major cardiovascular intervention within the first 30 days after the index angioplasty; need for carotid thrombectomy prior to stent implantation; absence of a negative pregnancy test in women of childbearing potential; severe allergy to iodinated contrast medium, not manageable with premedication; advanced stage renal failure, near initiation of renal replacement therapy, with nephrological contraindication to treatment; severe hemorrhagic diathesis to the extent that antiplatelet therapy is contraindicated; inability of the patient to maintain adherence to antiplatelet therapy, as determined by the patient own statement or by the clinical judgment of the treating team; presence of severe neurological sequelae that prevent the assessment of new clinical events during follow-up; presence of severely disabling systemic disease, with life expectancy under 12 months or an advanced directive for terminal or palliative care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find at least a 12% difference in the occurrence of stroke, transient ischemic attack, acute myocardial infarction, or death within 90 days between individuals with and without intra-stent plaque protrusion | — |
Secondary
| Measure | Time frame |
|---|---|
| A statistically significant difference is expected in the occurrence of neurological worsening, defined as an increase of four or more points on the NIHSS scale within the first 48 hours when comparing individuals with and without intra-stent plaque protrusion;A statistically significant difference is expected in the occurrence of unplanned medical reassessment and/or reintervention (pharmacological, surgical, endovascular) related to stent implantation within 90 days when comparing individuals with and without intra-stent plaque protrusion | — |
Countries
BR
Contacts
Public ContactLucas Cabral
Hospital de Clinicas de Porto Alegre
Outcome results
None listed