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news.Isotechnika, an international biopharmaceutical company, has announced that its partner, Atrium Medical, a medical device company, has completed patient enrollment for their Confirm 1, first-in-man drug coated coronary stent clinical trial evaluating Atrium's Cinatra voclosporin coated coronary stent system.
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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 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 Langenhove 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 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.
Trevor Carlton, president of Atrium, said: We are extremely pleased to have completed enrollment within our projected timelines. 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.