internal carotid artery stenosis
Conditions
Interventions
Carotid Wallstent
Precise stent
Sponsors
Wakayama Rosai Hospital Medical Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. High Risk Patient of CEA Symptomatic (within 180 days from onset) : >=50% Stenosis Asymptomatic : >=80% Stenosis 2. Age >= 20 and <80 years old 3. Independent daily life (mRS<=2) 4. Available for anti-platelet agents 5. Feasible of distal protection (Filterwire EZ) 6. Treatable lesion either by using either Carotid Wallstent or Precise stent Lesions with following two features are excluded from anatomical point of view. a) lesions totally surrounded by calcified plaque b) severe angulation between CCA-ICA (over 60 degree) 7. Available for MRI examination 8. CAS within 30 days after enrollment 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Previous treatment for the target lesion 2. Lesions considered to be non-atherosclerotic etiology 3. Recurrent symptom of cerebral ischemia within 48 hours before enrollment 4. Complete occlusion/pseudoocclusion 5. Coexistence of other symptomatic cerebral stenosis 6. Previous hemorrhagic stroke within 90 days before enrollment 7. Serological Creatinine over 2mg/dl 8. Pregnancy or possible pregnancy 9. Planned brain surgery or other endovascular treatment within 1 month 10. Inappropriate candidate for attending to the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| any ischemic stroke and severe disability or death by any causes within 30days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. new ischemic lesions detected by diffusion weighted images within 7 days after the treatment 2. intrastent plaque protrusion detected by IVUS, angiogram, CT angiography or carotid ultrasound within 7 days after the treatment | — |
Countries
Japan
Contacts
Public ContactHideo Okada
Wakayama Rosai Hospital Neurosurgery
Outcome results
None listed