NCT02722720

Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carotid Atherosclerosis
• Carotid Stenosis
• Ischemic Attack
• Stroke
• Bleeding

Interventions

Type	Name	Description
PROCEDURE	Transradial carotid artery stenting	The radial artery is punctured with a trocar. A guidewire is advanced through its lumen, and the trocar is withdrawn. An introducer is passed into the vessel. Then a standard endovascular procedure is carried out under local anesthesia and fluoroscopic control. To prevent cerebral embolism, a protection device is positioned distally of target lesion in internal carotid artery. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control stent is implanted. After removing all of devices a control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix (clopidogrel) in dose 300-600 mg prescription before the procedure and heparin sodium injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and Plavix (clopidogrel) in dose 75/d should be prescribed within 2 months.
PROCEDURE	Transfemoral carotid artery stenting	The common femoral artery is punctured with a trocar. A guidewire is advanced through its lumen, and the trocar is withdrawn. An introducer is passed into the vessel. Then a standard endovascular procedure is carried out under local anesthesia and fluoroscopic control. To prevent cerebral embolism, a protection device is positioned distally of target lesion in internal carotid artery. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control stent is implanted. After removing all of devices a control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix (clopidogrel) in dose 300-600 mg prescription before the procedure and heparin sodium injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and Plavix (clopidogrel) in dose 75/d should be prescribed within 2 months.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-03-30
• Last updated: 2017-06-29

Locations

1 site across 1 country: Russia