Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation
Primary Purpose
Carotid Stenosis, Carotid Artery Diseases
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Modified method of eversion carotid endarterectomy
Standard method of eversion carotid endarterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Stenosis focused on measuring carotid endarterectomy, eversion carotid endarterectomy, prophylaxis of ischemic stroke, carotid arteriosclerosis, carotid artery plasty
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Modified eversion
Standard eversion
Arm Description
Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy
Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a standard eversion carotid endarterectomy
Outcomes
Primary Outcome Measures
Assessment of total stroke rate
assessment of the total stroke rate in patients undergoing intervention after 30 days
Assessment of mortality rate
assessment of the mortality rate in patients undergoing intervention after 30 days
Secondary Outcome Measures
Assessment of stroke frequency
assessment of stroke frequency in patients undergoing intervention after 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
Full Information
NCT ID
NCT04255316
First Posted
January 27, 2020
Last Updated
January 14, 2021
Sponsor
Pirogov Russian National Research Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04255316
Brief Title
Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation
Official Title
Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pirogov Russian National Research Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis, Carotid Artery Diseases
Keywords
carotid endarterectomy, eversion carotid endarterectomy, prophylaxis of ischemic stroke, carotid arteriosclerosis, carotid artery plasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified eversion
Arm Type
Experimental
Arm Description
Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy
Arm Title
Standard eversion
Arm Type
Active Comparator
Arm Description
Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a standard eversion carotid endarterectomy
Intervention Type
Procedure
Intervention Name(s)
Modified method of eversion carotid endarterectomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard method of eversion carotid endarterectomy
Intervention Description
standard eversion technic
Primary Outcome Measure Information:
Title
Assessment of total stroke rate
Description
assessment of the total stroke rate in patients undergoing intervention after 30 days
Time Frame
30 days
Title
Assessment of mortality rate
Description
assessment of the mortality rate in patients undergoing intervention after 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Assessment of stroke frequency
Description
assessment of stroke frequency in patients undergoing intervention after 12 months
Time Frame
12 months
Title
Assessment of the incidence of internal carotid artery restenosis
Description
Assessment of the incidence of internal carotid artery restenosis after 3, 6 and 12 months
Time Frame
3, 6, 12 months
Other Pre-specified Outcome Measures:
Title
Evaluation of speed flow in carotid bifurcation by ultrasound duplex scan
Description
Evaluation of speed flow, peak systolic velocity (cm/s) in common carotid artery, internal carotid artery and external carotid artery and their ratios using ultrasound duplex scan.
Time Frame
24 hours, 30 days, 3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anatoly Virgansky, MD
Organizational Affiliation
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation
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