Custom Made Three Dimensional Printed Models for Pre-operative Planning and Simulation of Endovascular Treatment of Peripheral Artery Disease (3DPAD-1): A Single Blind Randomised Controlled Trial

Objective: This trial aimed to assess whether custom made three dimensional (3D) printed vascular models improve procedural outcomes when used for pre-operative planning and simulation in endovascular treatment (EVT) of aorto-iliac-femoropopliteal peripheral artery disease (PAD). Methods: This single centre, single blind randomised controlled trial (3DPAD-1), registered on ClinicalTrials.gov (Identifier: NCT07000097), enrolled consecutive patients scheduled for EVT between January 2022 and September 2024. Participants were randomised 1 : 1 to standard planning based on computed tomography angiography (CTA) alone (standard group, SG) or CTA plus 3D printed model based planning and simulation (3D model group, 3DMG). The prespecified coprimary endpoints were the cumulative 30 day incidence of peri-operative complications and total procedure duration. Secondary endpoints included technical success, contrast medium volume, radiation exposure, fluoroscopy time, and number of devices used. Results: Of 166 patients screened, 106 were randomised (53 per arm); 99 underwent the allocated intervention (48 in the 3DMG, 51 in the SG). The cumulative incidence of complications was significantly lower in the 3DMG (20.8%) than in the SG (49.0%; p = .006). The univariable logistic model (OR 0.27, 95% CI 0.11 - 0.66; p = .004), the multivariable model (adjusted OR 0.22, 95% CI 0.08 - 0.60; p = .004), and the propensity weighted analyses (Average Treatment Effect OR 0.33, 95% CI 0.13 - 0.86; p = .023; Average Treatment Effect in the Overlap Population OR 0.35, 95% CI 0.14 - 0.79; p = .023) consistently confirmed the protective effect of the 3D model. Procedure duration was significantly shorter in the 3DMG (mean difference -40.3 minutes; p < .001), confirmed in adjusted and weighted models. No significant between group differences were observed in other peri-operative outcomes. Conclusion: Custom made 3D printed models significantly reduced peri-operative complications and procedure duration in EVT for PAD, supporting their role in improving procedural planning and efficiency. These findings support the selective adoption of 3D printed models for complex endovascular interventions to enhance procedural efficiency and patient safety.