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Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

Primary Purpose

Carotid Atherosclerosis, Carotid Stenosis, Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Transradial carotid artery stenting
Transfemoral carotid artery stenting
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Atherosclerosis focused on measuring Carotid atherosclerosis, Carotid stenosis, Ischemic attack, Stroke, Carotid stenting, Transradial approach, Transfemoral approach, Bleeding, Thromboembolism, Embolism, Neurocognitive disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Research Institute of CIrculation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carotid stenting, Transradial approach

Carotid stenting, Transfemoral approach

Arm Description

Internal carotid artery stenting using transradial arterial approach

Internal carotid artery stenting using transfemoral arterial approach

Outcomes

Primary Outcome Measures

Cerebral embolism
Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data.

Secondary Outcome Measures

Cerebral embolism
Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination.
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.
Neurocognitive disorders
Mini-Mental State Examination (MMSE)
Neurocognitive disorders
Rey Auditory Verbal Learning Test (RALVT)
Neurocognitive disorders
Grooved Pegboard test
Neurocognitive disorders
Boston Naming Test
Neurocognitive disorders
Geriatric Depression Scale
Neurocognitive disorders
Weschler Test of Adult Reading (WTAR)
Device success
Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.
Lesion success
Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach.
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.
Operative access complications
Bleeding, aneurisms, large hematomas, atrioventricular fistula
Fluoroscopic time

Full Information

First Posted
March 13, 2016
Last Updated
June 28, 2017
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02722720
Brief Title
Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral
Official Title
Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carotid stenting, Transradial approach
Arm Type
Experimental
Arm Description
Internal carotid artery stenting using transradial arterial approach
Arm Title
Carotid stenting, Transfemoral approach
Arm Type
Active Comparator
Arm Description
Internal carotid artery stenting using transfemoral arterial approach
Intervention Type
Procedure
Intervention Name(s)
Transradial carotid artery stenting
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transfemoral carotid artery stenting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cerebral embolism
Description
Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data.
Time Frame
during 24 hours after carotid artery stenting
Secondary Outcome Measure Information:
Title
Cerebral embolism
Description
Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination.
Time Frame
intraoperative
Title
MACCE
Description
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.
Time Frame
during 30 days after carotid artery stenting
Title
Neurocognitive disorders
Description
Mini-Mental State Examination (MMSE)
Time Frame
before and 30 days after carotid artery stenting
Title
Neurocognitive disorders
Description
Rey Auditory Verbal Learning Test (RALVT)
Time Frame
before and 30 days after carotid artery stenting
Title
Neurocognitive disorders
Description
Grooved Pegboard test
Time Frame
before and 30 days after carotid artery stenting
Title
Neurocognitive disorders
Description
Boston Naming Test
Time Frame
before and 30 days after carotid artery stenting
Title
Neurocognitive disorders
Description
Geriatric Depression Scale
Time Frame
before and 30 days after carotid artery stenting
Title
Neurocognitive disorders
Description
Weschler Test of Adult Reading (WTAR)
Time Frame
before and 30 days after carotid artery stenting
Title
Device success
Description
Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.
Time Frame
intraoperative
Title
Lesion success
Description
Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach.
Time Frame
intraoperative
Title
In-hospital procedure success
Description
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.
Time Frame
Within 5-day hospitalization
Title
Operative access complications
Description
Bleeding, aneurisms, large hematomas, atrioventricular fistula
Time Frame
intraoperative/ 1 day after operation
Title
Fluoroscopic time
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

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