Interventional cardiology and radiology company CeloNova BioSciences said today it launched a trial of its novel Cobra PzF coronary stent for treating heart disease.
The e-Cobra study, a prospective registry in France, is slated to enroll 1,000 patients with a primary endpoint assessing the rate of major adverse cardiac events, such as cardiac death, myocardial infarction and lesion revascularization, at 12 months.
“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,” Dr. Alain Tavildari of Aix-en-Provence, France’s Clinique Axium said in a press release.
The study will be supervised by principal investigator Dr. Luc Maillard of the Clinique Axium, according to the company.
“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,” Dr. Maillard said in prepared remarks.
The Cobra PzF stent received CE Mark approval in the European Union in 2012, the company said.
“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. We will continue to support the development of compelling clinical evidence for this exciting stent platform,” CEO Martin Landon said in a prepared statement.