Isotechnika Inc. announced today that its partner, Atrium Medical Corporation has completed patient enrollment for their CONFIRM, First-in-Man (FIM) drug coated coronary stent clinical trial evaluating Atrium’s CINATRATM voclosporin coated coronary stent system.
This FIM trial is a prospective, multi-center, single blind, randomized, controlled study using the CINATRATM voclosporin coated coronary stent system, which will be compared to Atrium’s CINATRATM bare metal coronary stent (BMS) platform. This first use study of voclosporin on an implantable medical device enrolled 100 patients and is currently being 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 CINATRATM voclosporin coated 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.
“We are extremely pleased to have completed enrollment within our projected timelines,” said Trevor Carlton, Atrium’s President. “Our last patient is expected to have their six month follow-up procedure at the end of June 2009 with results available in the third quarter of this year.”
“The progress that Atrium has been able to achieve in such a short period of time is extremely exciting,” stated Dr. Robert Foster, Isotechnika’s Chief Executive Officer. “We look forward to sharing the results with both the scientific and investment communities later this year.”
The CINATRA™ Voclosporin Coated Coronary Stent System is comprised of a cobalt chromium bare metal stent mounted on a delivery balloon catheter. The stent and the balloon are coated with Atrium’s proprietary Omega-3 fatty acid coating technology utilizing voclosporin for its anti-inflammatory properties.