RE: RE: RE: RE: AtriumIt’s a wonderful thing to be enlightened.
Single-blind describes experiments where information that could introduce bias or otherwise skew the result is withheld from the participants, but the experimenter will be in full possession of the facts.
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 with Glenn Van Langenhove, MD, PhD of Middelheim Hospital, Antwerp, as the study's Principal Investigator. 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.