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Completed

NCT Number: NCT02722720

Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

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

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Key information

Conditions

Carotid Atherosclerosis Arterial Occlusive Diseases Bleeding Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Embolism Embolism and Thrombosis Hemorrhage Ischemic Attack Mental Disorders Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thromboembolism Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 A guidewire is advanced through its lumen, and the trocar is withdrawn.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

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2016
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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