CeloNova BioSciences, Inc. (CeloNova), a global medical device company that offers a family of innovative products based upon its proprietary PolyzeneTM-F nanocoating technology, today announced 1-year clinical trial results from the eCOBRA post-market study of the company’s COBRA PzFTM NanoCoated Coronary Stent (NCS) System.
The clinical trial results demonstrated 4.3% target lesion revascularization, 0.3% late stent thrombosis and 8.6% major adverse cardiovascular events in patients at high risk for bleeding and thrombosis. The average age of patients was 76 years old. Approximately 30% of patients studied were on oral anticoagulant (OAC) therapy, and 48% had Non–ST- segment elevation myocardial infarction (NSTEMI) or ST-Elevation myocardial infarction (STEMI) at clinical presentation.
“The data from this trial provides further evidence that COBRA PzF NCS is a safe and effective treatment, particularly in complex patients with heart disease,” said Luc Maillard, MD, principal investigator for the eCOBRA trial and Director of the Department of Cardiology, Clinique Axium, Aix-en-Provence, France. “Being able to provide an effective therapy that meets the needs of patients who are at higher risk of bleeding is of great clinical value.”
eCOBRA is a prospective, consecutively enrolled, observational, multi-center, all-comers study comprised of 1,026 patients across 17 centers, including patients with stable angina and acute coronary syndrome. The study is designed to evaluate the safety and effectiveness of COBRA PzF NCS in patients undergoing treatment of de novo coronary lesions where a drug-eluting stent (DES) is typically not indicated.
“I am very excited by eCOBRA’s outstanding results as they support COBRA PzF NCS’ ability to offer an individualized treatment option for a greatly underserved population of high-risk patients,” stated Jason Cone, CEO of CeloNova. “We look forward to further exploring its safety and efficacy in our first-of-its- kind COBRA REDUCE trial with ultra-short, 14-day DAPT.”
The COBRA REDUCE trial is the world’s first and only randomized control trial to assess 14-day DAPT after percutaneous coronary intervention (PCI) as compared to FDA-approved DES with 3 or 6-months of DAPT in patients on oral anticoagulant. For more information about this ongoing global clinical trial, please visit ClinicalTrials.gov.