Evaluation of 3D Rotational Angiography After EVAR

University Hospital, Lille

Status: Withdrawn

Conditions: Radiation Burn; Aortic Aneurysm, Abdominal

Treatments: Radiation: 3D rotational angiography (3DRA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02894749

2015-A00645-44 (Other Identifier)

2014_47

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

2D Angiography (2DA)

No Intervention group

Description:

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.

3D rotational angiography (3DRA)

Experimental group

Description:

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.

Treatment:

Radiation: 3D rotational angiography (3DRA)