Carotid AtherosclerosisNCT02722720
Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral
A study testing Transradial carotid artery stenting and Transfemoral carotid artery stenting in people with Carotid Atherosclerosis and Carotid Stenosis, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carotid Atherosclerosis, Carotid Stenosis, Ischemic Attack
- What is being tested?
- Transradial carotid artery stenting and Transfemoral carotid artery stenting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Institute of CIrculation Pathology
Novosibirsk, 630055
About this study
Official title: Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach
The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.
Read the 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.
- Conditions
- Carotid Atherosclerosis, Carotid Stenosis, Ischemic Attack, Stroke, Bleeding
- Being tested
- Transradial carotid artery stenting, Transfemoral carotid artery stenting
- Keywords
- Carotid atherosclerosis, Carotid stenosis, Ischemic attack, Stroke, Carotid stenting, Transradial approach, Transfemoral approach, Bleeding, Thromboembolism, Embolism, Neurocognitive disorders
- Medical subject headings
- Carotid Artery Diseases, Carotid Stenosis, Stroke, Hemorrhage, Thromboembolism, Embolism, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transradial carotid artery stentingProcedure or surgery
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 stentingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Carotid stenting, Transradial approach | Experimental | Internal carotid artery stenting using transradial arterial approach Receives: Procedure: Transradial carotid artery stenting |
| Carotid stenting, Transfemoral approach | Active comparator | Internal carotid artery stenting using transfemoral arterial approach Receives: Procedure: Transfemoral carotid artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral embolism
Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data.
Measured: during 24 hours after carotid artery stenting
Secondary outcomes (13)
Cerebral embolism
Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination.
Measured: intraoperative
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.
Measured: during 30 days after carotid artery stenting
Neurocognitive disorders
Mini-Mental State Examination (MMSE)
Measured: before and 30 days after carotid artery stenting
Neurocognitive disorders
Rey Auditory Verbal Learning Test (RALVT)
Measured: before and 30 days after carotid artery stenting
Neurocognitive disorders
Grooved Pegboard test
Measured: before and 30 days after carotid artery stenting
Neurocognitive disorders
Boston Naming Test
Measured: before and 30 days after carotid artery stenting
Neurocognitive disorders
Geriatric Depression Scale
Measured: before and 30 days after carotid artery stenting
Neurocognitive disorders
Weschler Test of Adult Reading (WTAR)
Measured: before and 30 days after carotid artery stenting
Device success
Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.
Measured: intraoperative
Lesion success
Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach.
Measured: intraoperative
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.
Measured: Within 5-day hospitalization
Operative access complications
Bleeding, aneurisms, large hematomas, atrioventricular fistula
Measured: intraoperative/ 1 day after operation
Fluoroscopic time
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722720
- Sponsor's protocol ID
- CASTE-1.0
- Status last verified
- Jun 2017
- First submitted
- 13 Mar 2016
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach
- ClinicalTrials.gov ID
- NCT02722720
- Acronym / sponsor ID
- CASTE-1.0
- Conditions
- Carotid Atherosclerosis, Carotid Stenosis, Ischemic Attack, Stroke, Bleeding
- Keywords
- Carotid atherosclerosis, Carotid stenosis, Ischemic attack, Stroke, Carotid stenting, Transradial approach, Transfemoral approach, Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid stenting, Transradial approach | Experimental | Procedure: Transradial carotid artery stentingInternal carotid artery stenting using transradial arterial approach |
| Carotid stenting, Transfemoral approach | Active comparator | Procedure: Transfemoral carotid artery stentingInternal carotid artery stenting using transfemoral arterial approach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transradial carotid artery stentingThe 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. | Procedure or surgery | Carotid stenting, Transradial approach |
| Transfemoral carotid artery stentingThe 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. | Procedure or surgery | Carotid stenting, Transfemoral approach |
Primary outcome
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.
13 secondary outcomes
Cerebral embolism
Time frame: intraoperative
MACCE
Time frame: during 30 days after carotid artery stenting
Neurocognitive disorders
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
Time frame: before and 30 days after carotid artery stenting
Device success
Time frame: intraoperative
Lesion success
Time frame: intraoperative
In-hospital procedure success
Time frame: Within 5-day hospitalization
Operative access complications
Time frame: intraoperative/ 1 day after operation
Fluoroscopic time
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transradial carotid artery stenting and Transfemoral carotid artery stenting in people with Carotid Atherosclerosis and Carotid Stenosis, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral embolism (time frame: during 24 hours after carotid artery stenting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.