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Anatomically complex airway stenosis (ACAS) represents a challenging situation in which commercially available stents often result in migration or granulation tissue reaction due to poor congruence. This proof-of-concept clinical trial investigated the feasibility and safety of computer-assisted designed (CAD) and manufactured personalised three-dimensional (3D) stents in patients with ACAS from various origins. After CAD of a virtual stent from a CT scan, a mould is manufactured using a 3D computer numerical control machine, from which a medical-grade silicone stent is made. Complication rate, dyspnoea, quality of life and respiratory function were followed after implantation. The congruence of the stent was assessed peroperatively and at 1 week postimplantation (CT scan). The stent could be implanted in all 10 patients. The 3-month complication rate was 40%, including one benign mucus plugging, one stent removal due to intense cough and two stent migrations. 9 of 10 stents showed great congruence within the airways, and 8 of 10 induced significant improvement in dyspnoea, quality of life and respiratory function. These promising outcomes in highly complex situations support further investigation on the subject, including technological improvements.​Trial registration numberNCT02889029.

Conversion of anatomic images into physical objects using three-dimensional printing (3DP) is changing the way surgeons anticipate selected technical challenges. We report herein a case of malignant central airway obstruction in the right main bronchus. Because stenting of the primary right carina is difficult, as it depends on many diameters and distance measurements, we used 3DP to plan and guide the procedure. After virtual resolution of the extrinsic compression, a three-dimensional printed model of the airways helped us choose the model and dimensions of the stent, and allowed us to modify its accuracy before insertion.

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