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Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

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ClinicalTrials.gov Identifier: NCT02722720
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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

Condition or disease Intervention/treatment Phase
Carotid Atherosclerosis Carotid Stenosis Ischemic Attack Stroke Bleeding Procedure: Transradial carotid artery stenting Procedure: Transfemoral carotid artery stenting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach
Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Carotid stenting, Transradial approach
Internal carotid artery stenting using transradial arterial approach
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 A guidewire is advanced through its lumen, and the trocar is withdrawn.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.

Active Comparator: Carotid stenting, Transfemoral approach
Internal carotid artery stenting using transfemoral arterial approach
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.




Primary Outcome Measures :
  1. Cerebral embolism [ Time Frame: during 24 hours after carotid artery stenting ]
    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 :
  1. Cerebral embolism [ Time Frame: intraoperative ]
    Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination.

  2. MACCE [ Time Frame: during 30 days after carotid artery stenting ]
    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.

  3. Neurocognitive disorders [ Time Frame: before and 30 days after carotid artery stenting ]
    Mini-Mental State Examination (MMSE)

  4. Neurocognitive disorders [ Time Frame: before and 30 days after carotid artery stenting ]
    Rey Auditory Verbal Learning Test (RALVT)

  5. Neurocognitive disorders [ Time Frame: before and 30 days after carotid artery stenting ]
    Grooved Pegboard test

  6. Neurocognitive disorders [ Time Frame: before and 30 days after carotid artery stenting ]
    Boston Naming Test

  7. Neurocognitive disorders [ Time Frame: before and 30 days after carotid artery stenting ]
    Geriatric Depression Scale

  8. Neurocognitive disorders [ Time Frame: before and 30 days after carotid artery stenting ]
    Weschler Test of Adult Reading (WTAR)

  9. Device success [ Time Frame: intraoperative ]
    Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.

  10. Lesion success [ Time Frame: intraoperative ]
    Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach.

  11. In-hospital procedure success [ Time Frame: Within 5-day hospitalization ]
    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.

  12. Operative access complications [ Time Frame: intraoperative/ 1 day after operation ]
    Bleeding, aneurisms, large hematomas, atrioventricular fistula

  13. Fluoroscopic time [ Time Frame: intraoperative ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722720


Locations
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Russian Federation
State Research Institute of CIrculation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02722720     History of Changes
Other Study ID Numbers: CASTE-1.0
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Carotid atherosclerosis
Carotid stenosis
Ischemic attack
Stroke
Carotid stenting
Transradial approach
Transfemoral approach
Bleeding
Thromboembolism
Embolism
Neurocognitive disorders

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Atherosclerosis
Hemorrhage
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases