Carotid StenosisNCT04255316
Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation
A study testing Modified method of eversion carotid endarterectomy and Standard method of eversion carotid endarterectomy in people with Carotid Stenosis and Carotid Artery Diseases, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
A prospective comparative randomized single-centre non-inferiority trial. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carotid Stenosis, Carotid Artery Diseases
- What is being tested?
- Modified method of eversion carotid endarterectomy and Standard method of eversion carotid endarterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2017to 1 Mar 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with stenosis of ICA 70-99% (ultrasound - NASCET and CT angiography)
- patients with a extensive lesion of the ICA (plaque < 2 cm) by ultrasound - NASCET and CT angiography
Who cannot join
- patients with a extensive lesion of the ICA (plaque < 2 cm),
- patients with a contralateral occlusion of the ICA
- patients with stroke in ischemic type in the acute period.
Trial locations and contacts
1 site in 1 country.
Russia1 site
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Moscow, 117997
About this study
A prospective comparative randomized single-centre non-inferiority trial. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation
Read the detailed description
Introduction. Performing eversion endarterectomy some difficulties arise. Firstly, it requires a great deal of coherence between the work of the surgeon and the first assistant, as well as a great experience of the latter. Secondly, in some cases, there are difficulties in visualizing the distal margin of the intima: in the absence of a rigid skeleton, the soft unchanged artery walls after removal of the plaque subside, making it difficult to visualize possible fragments of the intima. Thirdly, the cost of the error is high: with a random de-version, repeated eversion turns out to be impossible. It should be noted that the use of an eversion technique becomes difficult to implement, and sometimes impossible, with extended stenosis, since a very high allocation of the ICA is required, which increases the invasiveness of the operation and the difficulty of access. With prolonged stenosis, the carotid endarterectomy remains the option of choice. The modification used eversion carotid endarterectomy combines the advantages of both methods, and also eliminates the limitations of the carotid endarterectomy and eversion carotid endarterectomy.
The aim of study. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation
- Conditions
- Carotid Stenosis, Carotid Artery Diseases
- Being tested
- Modified method of eversion carotid endarterectomy, Standard method of eversion carotid endarterectomy
- Keywords
- carotid endarterectomy, eversion carotid endarterectomy, prophylaxis of ischemic stroke, carotid arteriosclerosis, carotid artery plasty
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified method of eversion carotid endarterectomyProcedure or surgery
Mini approach for CCA bifurcation - Clamping ICA, ECA and CCA - ICA is cut off with a scalpel at the mouth itself - Dissection of the ICA and ECA in the distal direction to the distal border of the atherosclerotic plaque - Endarterectomy - Performing of a new bifurcation of the CCA with prolene 7/0
Standard method of eversion carotid endarterectomyProcedure or surgery
standard eversion technic
| Study group | Role | What they receive |
|---|---|---|
| Modified eversion | Experimental | Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy Receives: Procedure: Modified method of eversion carotid endarterectomy |
| Standard eversion | Active comparator | Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a standard eversion carotid endarterectomy Receives: Procedure: Standard method of eversion carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of total stroke rate
assessment of the total stroke rate in patients undergoing intervention after 30 days
Measured: 30 days
Assessment of mortality rate
assessment of the mortality rate in patients undergoing intervention after 30 days
Measured: 30 days
Secondary outcomes (2)
Assessment of stroke frequency
assessment of stroke frequency in patients undergoing intervention after 12 months
Measured: 12 months
Assessment of the incidence of internal carotid artery restenosis
Assessment of the incidence of internal carotid artery restenosis after 3, 6 and 12 months
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Oct 2017
- Primary completion28 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anatoly Virgansky, MD, Principal investigator, The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255316
- Sponsor's protocol ID
- 23
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation
- ClinicalTrials.gov ID
- NCT04255316
- Acronym / sponsor ID
- 23
- Conditions
- Carotid Stenosis, Carotid Artery Diseases
- Keywords
- carotid endarterectomy, eversion carotid endarterectomy, prophylaxis of ischemic stroke, carotid arteriosclerosis, carotid artery plasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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.
A prospective comparative randomized single-centre non-inferiority trial. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation
Detailed description
Introduction. Performing eversion endarterectomy some difficulties arise. Firstly, it requires a great deal of coherence between the work of the surgeon and the first assistant, as well as a great experience of the latter. Secondly, in some cases, there are difficulties in visualizing the distal margin of the intima: in the absence of a rigid skeleton, the soft unchanged artery walls after removal of the plaque subside, making it difficult to visualize possible fragments of the intima. Thirdly, the cost of the error is high: with a random de-version, repeated eversion turns out to be impossible. It should be noted that the use of an eversion technique becomes difficult to implement, and sometimes impossible, with extended stenosis, since a very high allocation of the ICA is required, which increases the invasiveness of the operation and the difficulty of access. With prolonged stenosis, the carotid endarterectomy remains the option of choice. The modification used eversion carotid endarterectomy combines the advantages of both methods, and also eliminates the limitations of the carotid endarterectomy and eversion carotid endarterectomy.
The aim of study. The purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified eversion | Experimental | Procedure: Modified method of eversion carotid endarterectomyPatients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy |
| Standard eversion | Active comparator | Procedure: Standard method of eversion carotid endarterectomyPatients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a standard eversion carotid endarterectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with stenosis of ICA 70-99% (ultrasound - NASCET and CT angiography)
- patients with a extensive lesion of the ICA (plaque < 2 cm) by ultrasound - NASCET and CT angiography
Key exclusion criteria (3 listed)
- patients with a extensive lesion of the ICA (plaque < 2 cm),
- patients with a contralateral occlusion of the ICA
- patients with stroke in ischemic type in the acute period.
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 |
|---|---|---|
| Modified method of eversion carotid endarterectomyMini approach for CCA bifurcation - Clamping ICA, ECA and CCA - ICA is cut off with a scalpel at the mouth itself - Dissection of the ICA and ECA in the distal direction to the distal border of the atherosclerotic plaque - Endarterectomy - Performing of a new bifurcation of the CCA with prolene 7/0 | Procedure or surgery | Modified eversion |
| Standard method of eversion carotid endarterectomystandard eversion technic | Procedure or surgery | Standard eversion |
Primary outcome
Assessment of total stroke rate
Time frame: 30 days
assessment of the total stroke rate in patients undergoing intervention after 30 days
Assessment of mortality rate
Time frame: 30 days
assessment of the mortality rate in patients undergoing intervention after 30 days
2 secondary outcomes
Assessment of stroke frequency
Time frame: 12 months
Assessment of the incidence of internal carotid artery restenosis
Time frame: 3, 6, 12 months
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 15 Jan 2021.
- 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.
Anatoly Virgansky, MD principal investigator
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified method of eversion carotid endarterectomy and Standard method of eversion carotid endarterectomy in people with Carotid Stenosis and Carotid Artery Diseases, run by Pirogov Russian National Research Medical University 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 2 inclusion and 3 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 15 Jan 2021. 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?
Assessment of total stroke rate (time frame: 30 days). The study lists 2 primary outcomes in all. 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 15 Jan 2021.