The Custom III clinical trial was a 90-patient prospective study to assess the safety and efficacy of the Custom NX drug eluting stent system in patients with up to two de novo lesions treatable with up to 60mm of customizable stent length. The primary endpoint was major adverse cardiac events (MACE) at 30 days, with secondary endpoints of MACE at six months, binary restenosis, late loss, and stent thrombosis.
Custom III enrolled a challenging patient population, with 67% of the lesions classified as complex B2/C, an average lesion length of 19.8mm, and an average reference vessel diameter (RVD) of 2.6mm. The Custom III trial included some of the longest lesion lengths and smallest RVDs compared to previous drug eluting stent trials.
For the primary endpoint, MACE at 30 days, the rate was 2.2%, consisting of two in-hospital non Q-wave myocardial infarctions (MIs). At six-month follow-up the MACE rate for Custom III was 7.8%. There were zero deaths, zero Q-wave MIs, two non Q-wave MIs, or 2.2%, and five clinically driven target lesion revascularizations, or 5.6%. The in-stent late loss for Custom III at six-month follow-up was 0.17mm, the in-stent binary restenosis rate was 4.4%, and the neointimal hyperplasia (NIH) volume was 3.8%.
Bernard De Bruyne, principal investigator for the Custom III clinical trial, said: “The Custom III results are very promising and demonstrate the safety of in situ customization for treatment of simple and complex lesions. The IVUS and angiographic results confirm the efficacy of the Custom NX stent, and the Biolimus A9 and PLA formulation.”