About this trial
Patients with in-stent restenosis in carotid artery indicated to carotid intervention will be randomized into repeated carotid percutaneous transluminal angioplasty with or without stenting or carotid endarterectomy with stent removal. The objective of the randomized study is to compare the safety and effectiveness of CEA and CAS in patients with in-stent restenosis of the ICA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
In-stent restenosis in carotid artery 70 - 99 %
Indication to carotid intervention
Age 18-80 years
Functionally independent with a modified Rankin score value of 0 - 2 points
Disqualifiers
Contraindication to general anesthesia
Contraindication to angiography (iodine allergy, etc.)
Technically impossible to perform angioplasty with or without stenting
Participation in other clinical study within 60 days
Trial design
Parallel
Treatments tested in this trial
Carotid endarterectomy with stent removal
Procedure/SurgeryStandard carotid endarterectomy will be extended with the stent removal
Treatment groups
Trial outcomes
Primary outcomes
carotid stenosis
percentage of stenosis in treated carotid artery after intervention
Secondary outcomes
vascular morbidity within 30 days
ischemic stroke, hemorrhagic stroke, myocardial infarction and/or vascular death
Sponsors and contacts
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