CeloNova's e-COBRA Clinical Registry Begins Enrollment in France

September 14, 2015—CeloNova BioSciences, Inc. 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 company’s Cobra PzF coronary stent system in real-world and complex patients with heart disease. The device, which features a nanothin coating of the company's Polyzene-F polymer and a thin-strut design, received European CE Mark approval in 2012 and is available for sale in Europe and the Middle East.

In the announcement, Alain Tavildari, MD, from Clinique Axium, in Aix-en-Provence, France, commented, “We are excited to have the first French patient enrolled in the e-COBRA study. The Cobra PzF coronary stent system’s deliverability in this patient was excellent.”

The company advised that previous preclinical and first-in-man studies suggest that the Cobra PzF system is associated with rapid healing and re-endothelialization and may reduce stent thrombosis and restenosis without the use of long-term dual-antiplatelet therapy (DAPT). 

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 major adverse cardiac events (cardiac death, myocardial infarction, and clinically driven target lesion revascularization) at 12 months.

The study is supervised by Principal Investigator Luc Maillard, MD, with a scientific committee composed of Loic Belle, MD; Jacques Berland, MD; and Nicolas Delarche, MD.

Dr. Maillard, who is Director of the Department of Cardiology at Clinique Axium in Aix-en-Provence, France, commented in CeloNova’s press release, “The Cobra PzF stent could offer an excellent therapeutic alternative to patients at high risk of bleeding complications. Preclinical data suggest that a very short DAPT duration could be applied to those patients while guaranteeing a low restenosis rate.”