Stroke, not specified as hemorrhagic or ischemic
Conditions
Interventions
Patients with carotid stenosis above 70% who had symptoms of stroke will be included, they will be drawn by the coil flipping system and divided into two arms for treatment with carotid angioplasty an
Device
E04.100.814.868.500
Sponsors
Hospital de Clínicas de Ribeirão Preto - Universidade de São Paulo
Hospital da Cidade de Passo Fundo
Eligibility
Age
18 Years to 101 Years
Inclusion criteria
Inclusion criteria: Patient over 18 years of age; Life expectancy greater than 1 year; Internal carotid artery stenosis> or = 70% associated with ipsilateral symptoms such as TIA, stroke or retinal ischemia; Internal carotid artery stenosis> or = 70% asymptomatic
Exclusion criteria
Exclusion criteria: Contraindication for antiplatelet therapy; Contraindication for use of iodinated contrast media; Patients with stroke or TIA classified by A-S-C-O as C1 or O1, that is, they present mitral stenosis; prosthetic heart valve; AMI in the previous 4 weeks; mural thrombus in the left chambers; left ventricular aneurysm; documented history of chronic or transient AF or flutter with or without "spontaneous echo contrast"; thrombus in the left atrium; sinus node disease syndrome; dilated cardiomyopathy; FE 800,000; LES; criteria for SAAF; Fabry disease; sickle cell anemia; ruptured cerebral aneurysm, with or without demonstration of spasm in the cerebral infarct territory; homozygous for hyperhomocystinuria; acute arterial dissection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be: the occurrence of emboli (yes or no), which are easily detected in the MRI of the brain in the FLAIR and DWI sequence after carotid angioplasty, are considered as markers of ischemic events.;The primary outcome will be: the number of pistons (in numbers) and the size of the pistons (in millimeters). which are easily detected in the MRI of the brain in the FLAIR and DWI sequence after carotid angioplasty, are considered as markers of ischemic events.;The primary endpoint will be: the size of the emboli (in millisiters), which are easily detected in the MRI of the brain in the FLAIR and DWI sequence after carotid angioplasty, are considered as markers of ischemic events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: Stroke (Stroke). Neurological complications will be assessed by experienced stroke-certified vascular neurologists applying the Ramkin Modified and National Institute of Health Stroke Scale (NIHSS);The secondary outcomes are: Transient Ischemic Attack (TIA). Neurological complications will be assessed by experienced stroke-certified vascular neurologists applying the Ramkin Modified and National Institute of Health Stroke Scale (NIHSS) | — |
Countries
Brazil
Contacts
Public ContactJosé Vanzin
Hospital da Cidade de Passo Fundo
Outcome results
None listed