NCT04257942

Brief Summary

Endarterectomy of the carotid artery procedure will be performed at Sheba Medical center vascular surgery department, followed by fixation and histology. Tissues will then be transferred to Weizmann Institute of Science for observation implementing advanced electron microscopy techniques. Finally, joint evaluation of the results will be carried out, in relation to the patient clinical history.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Status
unknown

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

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

Same day

First QC Date

February 4, 2020

Last Update Submit

February 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • crystallization of cholesterol in atherosclerosis

    Understand the interrelation between structural, morphological and spatial characteristics of cholesterol crystals found within the atherosclerotic lesion and its maturation and destabilization.

    3 years

Interventions

carotid endarterctomy that is being used for carotid stenosis disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with carotid stenosis - symptomatic and asymptomatic

You may qualify if:

  • all patients that are being operated on for carotid endarterctomy due to carotid stenosis

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

atheromas that are being removed from arteries

MeSH Terms

Interventions

Endarterectomy, Carotid

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2020

Study Completion

June 30, 2021

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

only the pthological and clinical findings

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
2023- forever