Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

NCT01661686

Esophageal Cancer Esophageal Stenosis

COMPLETED NA

Brachial Versus Femoral Access for Carotid Artery Stenting

NCT06557135

Carotid Artery Stenosis Without Infarction (Disorder) Ischemic Stroke

RECRUITING NA

Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia

NCT01894763

Esophageal Cancer

COMPLETED PHASE1

Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction

NCT03821025

Bile Duct Obstruction, Extrahepatic Cancer of the Pancreas Cancer of the Bile Duct +1 more

UNKNOWN NA

Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus

NCT02971345

Hepatocellular Carcinoma Portal Vein Tumor Thrombus

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Stenosis Carotid Artery Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Modified eversion

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

Group Type EXPERIMENTAL

Modified method of eversion carotid endarterectomy

Intervention Type PROCEDURE

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 eversion

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

Group Type ACTIVE_COMPARATOR

Standard method of eversion carotid endarterectomy

Intervention Type PROCEDURE

standard eversion technic

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.