June 9, 2008 - Atrium Medical has begun enrollment of the first patients for their CONFIRM 1, First-in-Man (FIM) drug-eluting coronary stent clinical trial designed to evaluate the safety and performance of the stent.
The CINATRA voclosporin coated coronary stent system is a cobalt chromium balloon expandable stent, with a nonpolymer coating platform, mounted on a low profile rapid exchange catheter. Atrium's stent and balloon are both coated with Atrium's proprietary Omega 3 fatty acid coating technology, providing a more uniform bio-absorbable delivery vehicle for its anti-inflammatory compound, voclosporin.
This First-in-Man trial is a prospective, multicenter, 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, M.D., 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. Clinicians will assess patient outcomes, in addition to drug coated stent performance, by measuring late lumen loss, in-stent and in-segment lumen loss measurements at six months following implantation.
For more information: www.atriummed.com