Aortic Aneurysm, Abdominal, Radiation Burn
Conditions
Keywords
hybrid rooms, cone-beam computed tomography
Brief summary
This is a randomized prospective monocentric study to evaluate the benefits of a 3D rotational acquisition (3DRA) to assess technical success after treatment of infra-renal aneurysm with bifurcated endograft. Patients will be randomized between the standard strategy (2D angiography at the end of the procedure and angioCT-scan before discharge) and the new strategy (3DRA at the end of the procedure). Expected findings are a reduction of radiation exposure and contrast medium used during the hospital stay, with a similar resolution between angioCT-scan and 3DRA to depict the main complications after EVAR (occlusion, kinking, endoleak). Furthermore, any complication depicted after 3DRA group could benefit from an additional procedure during the same operating time, and therefore avoid a second intervention for the patient.
Interventions
RADIATION3D rotational angiography (3DRA)
3DRA allows CT-like reconstructions. It requires less X-rays and contrast medium than standard angioCT-scan. Furthermore, it can be performed in the operative room, during the procedure. Therefore, use of 3DRA should allow reduction of dose, contrast-medium and reintervention when compared to technical success assessment with angioCT-scan.
Sponsors
University Hospital, Lille
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients treated with EVAR for infra-renal aortic aneurysm * In a hybrid room * With a signed consent
Exclusion criteria
* Pregnant women * Patients unable to understand the study protocol or to give their consents * Renal insufficiency (eGFR\<60mL/min) * Ruptured aneurysms and other emergency settings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Dose | Single 1 day - At patient discharge | Total exposure to radiation in mSv |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Medium | Single 1 day - At patient discharge | Total amount of contrast medium used (mg of Iodine) |
| Reintervention rate | During the first 30 days | Number of secondary procedures due to initial technical issues in both group during the first month |
| Additional procedure | During surgery | Number of additional unplanned procedures during the initial operating time, thanks to complications depicted by respectively the 2D angiography or the 3D rotational angiography. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORStephan Haulon, MD, PhD
University Hospital, Lille
Outcome results
None listed