CeloNova BioSciences (CN) has announced that it enrolled the first patient in its multicenter e-COBRA clinical study in France.
This prospective registry will further assess the safety and efficacy of the novel COBRA PzF coronary stent system in real world and complex patients with heart disease.
Previous preclinical and First-in-Man studies suggest that the COBRA PzF coronary stent system, with its advanced nano-coating and thin-strut design, is associated with rapid healing and re-endothelialization, and may reduce stent thrombosis and restenosis without the use of long term blood thinning medication.
"We are excited to have the first French patient enrolled in the e-COBRA study," said Alain Tavildari, MD, from Clinique Axium, in Aix-en-Provence, France. "The COBRA PzF coronary stent system’s deliverability in this patient was excellent."
The e-Cobra registry is expected to enroll up to 1,000 patients from 50 centers in France. Its primary endpoint will assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization) at 12 months.
The study is supervised by Principal Investigator Luc Maillard, MD, Director of the Department of Cardiology, Clinique Axium, Aix-en-Provence, France, with a distinguished scientific committee composed of Loic Belle, MD; Jacques Berland, MD; and Nicolas Delarche, MD.
"The COBRA PzF stent could offer an excellent therapeutic alternative to patients at high risk of bleeding complications," Dr. Maillard said. "Preclinical data suggest that a very short DAPT duration could be applied to those patients while guaranteeing a low restenosis rate."
"The team at CeloNova is dedicated to supporting the growing body of clinical research necessary to bring forth disruptive technologies that can help improve the quality of life for patients," said Martin Landon, President and CEO, CeloNova Biosciences, Inc. "We will continue to support the development of compelling clinical evidence for this exciting stent platform."
CeloNova’s COBRA PzF coronary stent system received CE Mark approval in 2012 and is available for sale in Europe and the Middle East.