Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722720
• Other study ID #: CASTE-1.0
• Status: Completed
• Phase: N/A
• First received: March 13, 2016
• Last updated: June 28, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Bleeding
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Carotid Stenosis
• Hemorrhage
• Ischemic Attack
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral embolism	Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data.	during 24 hours after carotid artery stenting
Secondary	Cerebral embolism	Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination.	intraoperative
Secondary	MACCE	Major adverse cardiac and cerebrovascular events (MACCE) including: including: All-cause mortality, Myocardial infarction, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.	during 30 days after carotid artery stenting
Secondary	Neurocognitive disorders	Mini-Mental State Examination (MMSE)	before and 30 days after carotid artery stenting
Secondary	Neurocognitive disorders	Rey Auditory Verbal Learning Test (RALVT)	before and 30 days after carotid artery stenting
Secondary	Neurocognitive disorders	Grooved Pegboard test	before and 30 days after carotid artery stenting
Secondary	Neurocognitive disorders	Boston Naming Test	before and 30 days after carotid artery stenting
Secondary	Neurocognitive disorders	Geriatric Depression Scale	before and 30 days after carotid artery stenting
Secondary	Neurocognitive disorders	Weschler Test of Adult Reading (WTAR)	before and 30 days after carotid artery stenting
Secondary	Device success	Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.	intraoperative
Secondary	Lesion success	Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach.	intraoperative
Secondary	In-hospital procedure success	Procedure success is defined as achievement of a final residual diameter stenosis 20% together with the absence of any in-hospital major adverse cardiac event.	Within 5-day hospitalization
Secondary	Operative access complications	Bleeding, aneurisms, large hematomas, atrioventricular fistula	intraoperative/ 1 day after operation
Secondary	Fluoroscopic time		intraoperative