Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

Completed

Phase N/A Results N/A

Trial Description

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

Interventions

  • Transradial carotid artery stenting Procedure
    Intervention Desc: 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 A guidewire is advanced through its lumen, and the trocar is withdrawn.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.
    ARM 1: Kind: Experimental
    Label: Carotid stenting, Transradial approach
    Description: Internal carotid artery stenting using transradial arterial approach
  • Transfemoral carotid artery stenting Procedure
    Intervention Desc: 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 A guidewire is advanced through its lumen, and the trocar is withdrawn.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.
    ARM 1: Kind: Experimental
    Label: Carotid stenting, Transfemoral approach
    Description: Internal carotid artery stenting using transfemoral arterial approach

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Cerebral embolism during 24 hours after carotid artery stenting Yes
Secondary MACCE during 30 days after carotid artery stenting Yes
Secondary Neurocognitive disorders before and 30 days after carotid artery stenting Yes
Secondary Device success intraoperative Yes
Secondary Lesion success intraoperative Yes
Secondary In-hospital procedure success Within 5-day hospitalization Yes
Secondary Operative access complications intraoperative/ 1 day after operation Yes
Secondary Fluoroscopic time intraoperative Yes

Sponsors