Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls

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

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2020-02-07

Brief Summary

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Endovascular revascularization has revolutionized the field of vascular surgery and has become the first-choice treatment for peripheral arteries occlusive disease. However, the drawback of this technic is the X-ray exposure for both patients and staff and the iodinated contrast injection for the patient.

One way to reduce both radiation and contrast use is to use advanced imaging techniques allowing an overlay of a 3D vascular mask (from a pre-operative CT scan) onto the live X-ray image. This has been proven during endovascular aneurysm repair.

This advanced imaging application is currently available only in the latest expensive hybrid operating rooms, requires additional manoeuvre from the operator throughout the procedure, and may be X-rays and contrast consuming.

This trial will examine the clinical benefits based on patient and staff' radiation exposure during aorto-iliac revascularisation, of a new software imaging guidance, suitable for any theatre including those equipped with mobile C-arm, fully automated and with a radiation free overlay registration process.

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Detailed Description

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Conditions

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Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control with imaging guidance

Group Type EXPERIMENTAL

Control with imaging guidance

Intervention Type DEVICE

Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure using the automated overlay imaging guidance, in addition to the application of the ALARA principles.

The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).

Control without imaging guidance

Group Type ACTIVE_COMPARATOR

Control without imaging guidance

Intervention Type DEVICE

Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure not using the automated overlay imaging guidance, in addition to the application of the ALARA principles.

The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).

Interventions

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Control with imaging guidance

Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure using the automated overlay imaging guidance, in addition to the application of the ALARA principles.

The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).

Intervention Type DEVICE

Control without imaging guidance

Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure not using the automated overlay imaging guidance, in addition to the application of the ALARA principles.

The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).

Intervention Type DEVICE