This first-in-man trial is a prospective, multi-center, single-blind, randomized, controlled study using the Cinatra voclosporin-coated coronary stent system, which will be compared to Atrium’s Cinatra bare metal coronary stent (BMS) platform. This first use study of voclosporin on an implantable medical device will enroll 100 patients, and will be conducted at seven hospitals in Belgium.
The primary endpoint of the trial is to evaluate the safety and performance of the Cinatra voclosporin-coated coronary stent system and the Cinatra BMS coronary stent system in patients with de novo coronary artery disease.
Patient outcomes, in addition to drug coated stent performance, will be assessed by measuring late lumen loss, in-stent and in-segment lumen loss measurements at six months following implantation.
Atrium’s Cinatra voclosporin-coated coronary stent system is an advanced cobalt chromium balloon expandable stent, mounted on a low profile rapid exchange catheter.