NCT04255316

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

January 27, 2020

Last Update Submit

January 14, 2021

Conditions

Carotid StenosisCarotid Artery Diseases

Keywords

carotid endarterectomyeversion carotid endarterectomyprophylaxis of ischemic strokecarotid arteriosclerosiscarotid artery plasty

Outcome Measures

Primary Outcomes (2)

  • Assessment of total stroke rate

    assessment of the total stroke rate in patients undergoing intervention after 30 days

    30 days

  • Assessment of mortality rate

    assessment of the mortality rate in patients undergoing intervention after 30 days

    30 days

Secondary Outcomes (2)

  • Assessment of stroke frequency

    12 months

  • Assessment of the incidence of internal carotid artery restenosis

    3, 6, 12 months

Other Outcomes (1)

  • Evaluation of speed flow in carotid bifurcation by ultrasound duplex scan

    24 hours, 30 days, 3, 6 and 12 months

Study Arms (2)

Modified eversion

EXPERIMENTAL

Patients with extensive atherosclerotic lesion of the carotid bifurcation (more 25mm in internal carotid artery) undergo a modified eversion carotid endarterectomy

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

Procedure: Standard method of eversion carotid endarterectomy

Interventions

Modified method of eversion carotid endarterectomyPROCEDURE

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

Modified eversion
Standard method of eversion carotid endarterectomyPROCEDURE

standard eversion technic

Standard eversion

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, Russia

Location

MeSH Terms

Conditions

Carotid StenosisCarotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anatoly Virgansky, MD

    The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 5, 2020

Study Start

October 1, 2017

Primary Completion

February 28, 2020

Study Completion

March 1, 2020

Last Updated

January 15, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)