Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03546881 |
| Other study ID # |
RC17_0473 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 18, 2018 |
| Est. completion date |
October 16, 2019 |
Study information
| Verified date |
May 2023 |
| Source |
Nantes University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Study the Patient and staff Safety regarding the radiation exposure during the procedure with
and without the fusion imaging guidance technology in treatment of peripheral artery disease.
Description:
The investigators are proposing a prospective, monocentric trial to assess the use of fusion
imaging in peripheral endovascular revascularisation. The main aim of this research is to
prove that using fusion imaging guidance during peripheral endovascular revascularisation
improve the patient and staff safety in the theatre, through a reduction of radiation
exposure.
Peripheral artery occlusive disease (PAOD) is a worldwide well known disease, with
atherosclerosis as a leading cause. One third of patients with PAOD are symptomatic,
typically presenting with claudication, and in a very much less proportion with critical limb
ischemia. These last patients are high risk for major limb amputation without
revascularisation. Once symptomatic PAOD diagnosed, a CT-scan is required to assess the
anatomy and if indicated an endovascular revascularisation of the lower limbs arteries is
performed. This minimally invasive procedure allows the improvement of the hemodynamic flow
into the lower limb, by positioning one or several stents inside the diseased arteries
through a femoral or an humeral access under live X-rays (fluoroscopy) guidance.
X-rays are good at showing bones and radio-opaque endovascular tools, but they do not show
soft tissues like the arteries, and they produce flat (2D) images that superimpose all the 3D
anatomical features. In order to see the arteries, physicians have to inject iodinated
contrast during high quality imaging recording, which can be toxic for the kidneys, and
increases the amount of radiation used. Consequently, the drawbacks of this mini-invasive
procedure are the X-rays radiation exposure for both patients and medical staff, and the need
of iodinated contrast injection that can lead to lifelong kidney problems. Reducing both in
order to decrease their respective toxicities must be a priority for the endovascular
therapist. Several studies including guidelines recall basic safety standards for protection
against X-rays and iodinated contrast exposure.
One way to reduce both radiation and contrast use is to improve clinicians' perception of
intraoperative 3D vascular anatomy. Advanced imaging techniques allow overlay of a 3D version
of the aorta from a pre-operative CT scan (a 3D vascular mask) onto the live X-ray image
creating a '3D roadmap' - a virtual reality that helps guide surgery. It has been proven that
using fusion imaging guidance during aortic endovascular repair reduce both contrast and
radiation dose, especially if the registration protocol is contrast and almost radiation
free. The investigators have recently completed research showing that they are able to use an
advanced imaging application to dramatically reduce our radiation dose for complex aneurysms.
Traditionally, this advanced imaging application is currently available only in modern
expensive hybrid theatres, and not used in everyday practice during peripheral endovascular
revascularisation procedures. However new technologies are about to supply similar imaging to
any interventional equipment, which will change the way endovascular procedures are performed
worldwide. That's why using fusion imaging guidance routinely as a standard of care may be
part of good practice to improve patient and staff safety. However, to our knowledge, the
impact of using fusion on radiation dose and contrast use has not been validated for
peripheral endovascular procedures.
This trial will examine the clinical benefits of using fusion imaging guidance during
peripheral endovascular revascularisation procedures based on the radiation exposure, as
compared with procedures without imaging guidance. The design of the study is to compare a
prospective single centre cohort of 88 consecutive patients scheduled for an endovascular
peripheral procedure and randomised either as using the imaging guidance overlay, or to a
control cohort of patients whose procedure will be performed without imaging guidance
(standard of care).
This study is a Low risk and constraints study, because it's a standard care procedure with
no additional risks.
