Safety of Fusion Guidance During Peripheral Revascularisation

NCT ID: NCT03546881

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2019-10-16

Brief 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.

Detailed 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.

Conditions

Arteriopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Arm with fusion imaging guidance technology

arm with fusion imaging guidance technology to perform the endovascular surgery, in addition to the traditional 2D X-ray screen system.

Group Type: EXPERIMENTAL

fusion imaging guidance technology

Intervention Type: PROCEDURE

Imaging fusion guidance overlay used during PAOD endovascular revascularisation

2D X-ray screen

Intervention Type: PROCEDURE

2D X-ray screen during PAOD endovascular revascularisation

Arm without fusion imaging guidance technology

arm without fusion imaging guidance technology, using the traditional 2D X-ray screen system, to perform the endovascular surgery.

Group Type: ACTIVE_COMPARATOR

2D X-ray screen

Intervention Type: PROCEDURE

2D X-ray screen during PAOD endovascular revascularisation

Interventions

fusion imaging guidance technology

Imaging fusion guidance overlay used during PAOD endovascular revascularisation

Intervention Type: PROCEDURE

2D X-ray screen

2D X-ray screen during PAOD endovascular revascularisation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Willing and able to give informed consent
• Male or Female
• Aged 18 or older
• Have been scheduled for peripheral endovascular revascularisation of an occlusive arterial disease excluding isolated infra popliteal revascularisation
• Who have had a pre-operative diagnostic CT scan
• Able (in the investigator's opinion) and willing to comply with the study requirements
• Covered by the French public health insurance system

Exclusion Criteria

• Female under the age of 50 years old.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Any patient requiring an associated procedure: renal or mesenteric angioplasty.
• Adult under guardianship or trusteeship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Blandine Maurel, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes University Hospital, Vascular surgery, Institut du Thorax

Nantes, , France

Countries

France

Other Identifiers

RC17_0473

Identifier Type: -

Identifier Source: org_study_id