Atrium Medical Corporation (Atrium Medical), is planning to complete the CONFIRM 1 for CINATRA voclosporin coated coronary stent system by February 2014. The study will compare CINATRA ISA 247 Coated Coronary Stent System to the CINATRA Coronary Stent System. The trial is being conducted in Belgium.
This first in man study is a prospective, multicentre, single blind, randomized, controlled clinical trial which is currently enrolling approximately 100 participants. The follow up will occur at one month, six months, and one to five years post procedure. At six month follow up repeat angiography and IVUS will be performed for all patients. The principal investigator is Glenn Van Langenhove, MD, Middelheim Hospital, Antwerp, Belgium.
CINATRA voclosporin coated coronary stent system is an advanced cobalt chromium balloon expandable stent, mounted on a low profile rapid exchange catheter. Stent and balloon of the system are both coated with O3FA coating technology, providing a more uniform bio-absorbable delivery vehicle for its anti-inflammatory compound, voclosporin. Voclosporin is a calcineurin inhibitor and was selected for its desired anti-inflammatory properties in the vascular system.
The official title of the trial is “COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms.”