Fluoroscopy with MRA fusion image guidance in endovascular iliac artery interventions: study protocol for a randomized controlled trial (3DMR-Iliac-roadmapping study)

Abstract

BackgroundEndovascular iliac artery interventions rely on the use of two-dimensional digital subtraction angiographies with an iodinated contrast agent and ionizing radiation. The amount of iodinated contrast agent should be limited because of its potentially nephrotoxic effects. Three-dimensional (3D) image fusion requires registration of a preprocedural magnetic resonance angiogram (MRA) or computed tomography (CT) angiogram to a perprocedurally acquired cone-beam CT or two fluoroscopic orthogonal projections. After registration, the 3D angiography images can be overlaid on the fluoroscopy screen and will follow table and C-arm movements. This study will assess the added value of the 3D image fusion technique in iliac artery interventions regarding the amount of the iodinated contrast agent administered.Methods/DesignThe study cohort will comprise 106 patients (> 18 years) with symptomatic common and/or external iliac artery stenoses or occlusions and a recent (< 6 months) diagnostic MRA from the pelvis through the lower extremities, for which an endovascular intervention is indicated. Patients will be randomized into the control or study group (i.e. treatment without or with 3D image fusion guidance). The primary endpoint is the amount of administered iodinated contrast agent (mL). Secondary outcomes are technical success of the procedure, defined as < 30% residual stenosis over the treated lesion, fluoroscopy time, and radiation dose as dose area product (mGycm2). Patient participation in the study will be completed after hospital discharge.DiscussionThis study is a randomized controlled multicenter trial to provide evidence on the effect of the 3D image fusion technique on the amount of administered iodinated contrast during endovascular common and/or external iliac artery interventions.Trial registrationNederlands Trial Register, NTR5008. Registered on 16 December 2014.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2981-0) contains supplementary material, which is available to authorized users.

Novel diagnostic and imaging techniques in endovascular iliac artery procedures

“…nl/; identifier NTR5008; registered on 16 December 2014) was the first prospective, multicenter, randomized trial designed to evaluate whether 3D image fusion during endovascular iliac artery interventions could reduce the amount of administered iodinated CM. The study protocol, which was approved by the Maastricht University Medical Center+ and Maastricht University ethics committee (METC azM/UM), was previously published [70], and all study procedures were conducted in accordance with good clinical practices and applicable laws.…”

Fusion Imaging with a Mobile C-Arm for Peripheral Arterial Disease

“…Preliminary studies on fusion imaging for lower extremities revascularization was reported in several studies for iliac lesions. [10][11][12] At the moment, fusion imaging is not used routinely for the treatment of femoro-popliteal lesions. Moreover, this technology was described only in hybrid rooms equipped with fixed plane sensors.…”

Robust Self-Supervised Learning of Deterministic Errors in Single-Plane (Monoplanar) and Dual-Plane (Biplanar) X-Ray Fluoroscopy

“…To address the above issues (i.e. reducing fluoroscopy time and the amount of contrast), image fusion of preoperative 3D computed tomography angiogram (CTA) or magnetic resonance angiogram (MRA) with intraoperative fluoroscopy can be utilized [8]- [10]. As noted in [11] this image fusion step can be performed as either 2D-3D registration or 3D-3D registration.…”