Evaluation of 3D Rotational Angiography After EVAR

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of 3D Rotational Angiography After EVAR

Conditions
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Radiation Burn, Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Radiation: 3D rotational angiography (3DRA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2D Angiography (2DA)<br>Standard of care - Patients benefit from a 2D completion angiogram at the end of the procedure, and from a angioCT-scan before discharge. If any technical issues is depicted on the CT-scan, a new intervention needs to be scheduled. | |
| Experimental: 3D rotational angiography (3DRA)<br>New strategy - Patients benefit from a 3D rotational acquisition at the end of procedure, which offers CT-like reconstructions. If any technical issues is depicted on the 3DRA, it can be treated during the same operating time. A contrast-enhanced ultrasound is performed for each patient before discharge to confirm that no technical issue was missed by the 3DRA. | Radiation: 3D rotational angiography (3DRA)<br>* 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.<br>* Other names: Cone-beam CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Dose | Total exposure to radiation in mSv | Single 1 day - At patient discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast Medium | Total amount of contrast medium used (mg of Iodine) | Single 1 day - At patient discharge | 
| Reintervention rate | Number of secondary procedures due to initial technical issues in both group during the first month | During the first 30 days | 
| Additional procedure | Number of additional unplanned procedures during the initial operating time, thanks to complications depicted by respectively the 2D angiography or the 3D rotational angiography. | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hybrid rooms, cone-beam computed tomography