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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization

Treatments: Device: Control with imaging guidance; Device: Control without imaging guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT03713450

RC18_0092

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18 or older,
• Patients scheduled for aorto iliac endovascular revascularisation,
• Pre-operative CT scan.

Exclusion criteria

• Women of childbearing age,
• Absence of preoperative CT scan,
• Emergency procedures.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

45 participants in 2 patient groups

Control with imaging guidance

Experimental group

Treatment:

Device: Control with imaging guidance

Control without imaging guidance

Active Comparator group

Treatment:

Device: Control without imaging guidance