Multistage Preclinical Evaluation of MRI-Guided Stenting for Coarctation of the Aorta using in vitro and Porcine Models

Abstract Purpose This study evaluated the technical and procedural feasibility of MRI-guided stent implantation for CoA using a structured multistage preclinical evaluation protocol. Materials and methods A commercially available MR Conditional guidewire and dedicated research prototypes comprising nitinol stents, delivery systems, and balloon catheters were assessed in a three-stage protocol. Device visibility was evaluated in a standardized water phantom at 1.5 T and 3.0 T. In a polymer-based CoA vessel phantom, 10 stent implantations were performed by novices ( n = 6) and experts ( n = 4), with four separate expert-led balloon dilatations. MRI-guided stent implantation was subsequently performed in five porcine models. Results All devices were visible at both field strengths, with lateral artifact widths of 5.3–7.8 mm for the guidewire, 20.9–38.5 mm for the stent delivery system, 13.1–19.9 mm for the expanded stents, and 17.4–30.5 mm for the balloon catheter. Phantom stenting duration was 10.2 ± 7.2 mins for novices and 6.2 ± 2.7 mins for experts. MRI-guided stent implantation was successfully performed in all five animals, with a mean duration of 13.6 ± 7.5 mins. In one animal, balloon post-dilatation was additionally performed as a procedural proof of concept. Conclusion MRI-guided stent implantation for CoA is feasible within a structured multistage preclinical evaluation protocol and supports further clinical translation of radiation-free endovascular treatment.