Safety and Efficacy Evaluation of a Novel High-Frequency Automated-Pullback Peripheral Intravascular Ultrasound System in a Porcine Model

Vollständiger Abstract

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Objective: To evaluate the efficacy and safety of a novel single-use peripheral intravascular ultrasound (IVUS) system in a porcine model. Methods: Six healthy white pigs were randomized into 2 groups. The Efficacy Valuation Group (group A, self-controlled, n = 3) underwent imaging before and after stent implantation with both the test device (automated pullback) and a control IVUS system (manual pullback). The Safety Evaluation Group (group B, n = 3) was imaged with the test device only for safety and pathological evaluation. Endpoints included mean stent cross-sectional area (MSA), stent length, measurement agreement, image quality, device usability, vital signs, adverse events, and vascular safety. Results: For the primary endpoint, the 95% confidence intervals (CIs) for the relative difference in MSA between devices fell within the prespecified ±10% equivalence margin at both low-speed (2.010%-4.649%) and high-speed (0.844%-6.968%) pullback, as confirmed by two one-sided tests (TOST). A prespecified subgroup analysis by vessel type (arterial vs venous) confirmed consistent equivalence within each subgroup. The 95% limits of agreement for MSA were within ±1.5 mm 2 for both speeds. Stent length measurements correlated excellently with digital subtraction angiography ( r = .997, P < .0001). Lumen measurements showed good inter-device agreement. Both systems achieved a 100% image-quality excellence rate. Operators rated the test device significantly higher for overall usability (4.8 ± 0.4 vs 4.5 ± 0.5, P < .05). All animals remained hemodynamically stable with no device-related adverse events, and pathological examination revealed no significant vascular injury. It should be noted that key study limitations include the comparison of automated versus manual pullback, potential data clustering from multiple measurements per animal, and the use of a healthy animal model that does not replicate human atherosclerotic disease. Conclusion: In a porcine model, the novel high-frequency automated-pullback IVUS system demonstrated imaging efficacy noninferior to a control device, with a favorable safety profile and no observed complications. These preclinical findings support its further clinical investigation for peripheral vascular interventions. Clinical Impact This preclinical study demonstrates that a novel peripheral IVUS system, featuring a higher-frequency transducer (30 MHz) and automated pullback, achieves imaging efficacy and acute safety comparable to a control device in a porcine model. The higher-frequency design may improve resolution, and automated pullback enables standardized, operator-independent measurements. These features could enhance procedural planning for complex interventions. The system clearly visualized vessel microstructures, supporting more precise device selection with the potential to improve outcomes in precision vascular medicine. Future clinical studies are warranted to translate these advancements into clinical benefits for patients with atherosclerotic arterial or relevant venous diseases.