Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

NCT02722720 | Completed

• 1 other identifier: CASTE-1.0
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carotid Atherosclerosis; Carotid Stenosis; Ischemic Attack; Stroke; Bleeding

Keywords

Carotid atherosclerosis; Carotid stenosis; Ischemic attack; Stroke; Carotid stenting; Transradial approach; Transfemoral approach; Bleeding; Thromboembolism; Embolism; Neurocognitive disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Cerebral embolism

  intraoperative

• MACCE

  during 30 days after carotid artery stenting

• Neurocognitive disorders

  before and 30 days after carotid artery stenting

• Neurocognitive disorders

  before and 30 days after carotid artery stenting

• Neurocognitive disorders

  before and 30 days after carotid artery stenting

Study Arms (2)

Carotid stenting, Transradial approach

EXPERIMENTAL

Internal carotid artery stenting using transradial arterial approach

Procedure: Transradial carotid artery stenting

Carotid stenting, Transfemoral approach

ACTIVE COMPARATOR

Internal carotid artery stenting using transfemoral arterial approach

Procedure: Transfemoral carotid artery stenting

Interventions

Transradial carotid artery stenting PROCEDURE

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 A guidewire is advanced through its lumen, and the trocar is withdrawn.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.

Carotid stenting, Transradial approach

Transfemoral carotid artery stenting PROCEDURE

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.

Carotid stenting, Transfemoral approach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Stenosis; Stroke; Hemorrhage; Thromboembolism; Embolism; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2016
• First Posted: March 30, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)