Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carotid Atherosclerosis
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Cerebral embolism
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.
Detailed Description
The use of transradial approach in carotid arteries stenting can significantly decrease the amount of adverse events associated with transfemoral approach such as bleeding or hematoma. Otherwise providing transradial approach is fraught with technical difficulties of common carotid artery canulation that can result in embolic complications. Taking into account the absence of studies in this area of medicine, providing investigation evaluating parameters of safety for both methodics is very actual.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptomatic patients with internal carotid artery stenosis(\>50%)
- •Asymptomatic patients with internal carotid artery stenosis(\>60%)
- •Anatomy of internal carotid artery applicable for stent implantation and use of embolic protection device
Exclusion Criteria
- •Stroke, myocardial infarction or underwent operative treatment within 1 month
- •Prior carotid artery stenting
- •Cerebral vessels aneurisms/ malformations
- •Subclavian artery/ brachiocephalic trunk stenosis
- •Contraindications for antiplatelet or/and anticoagulation therapy
Outcomes
Primary Outcomes
Cerebral embolism
Time Frame: during 24 hours after carotid artery stenting
Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data.
Secondary Outcomes
- Neurocognitive disorders(before and 30 days after carotid artery stenting)
- Device success(intraoperative)
- Lesion success(intraoperative)
- Cerebral embolism(intraoperative)
- MACCE(during 30 days after carotid artery stenting)
- Operative access complications(intraoperative/ 1 day after operation)
- Fluoroscopic time(intraoperative)
- In-hospital procedure success(Within 5-day hospitalization)