CeloNova Biosciences said today that the FDA approved an expansion of the on-going clinical trial for its Cobra PzF nano-coated coronary stent with 14-day dual antiplatelet therapy in complex patients, like people who are at a high risk of bleeding.
The company touted its Cobra Reduce trial as the first randomized control trial to study 14-day DAPT following percutaneous coronary intervention.
“High bleeding risk patients currently have limited stent treatment options available to them primarily due to the duration of DAPT required,” co-lead investigator Dr. Robert Byrne said in prepared remarks. “The Cobra Reduce trial aims to provide clinical insights into optimal stent selection and eliminate the compromise between the risk of bleeding or stent thrombosis.”
The trial is slated to compare CeloNova’s Cobra device, which is composed of an ultra-thin polyzene-F fluoropolymer, with FDA-approved drug-eluting stents. The 996-patient study will assess whether the nano-coated coronary stent can improve clinical outcomes with 14 days of DAPT compared to drug-eluting stents with three or six months of DAPT.
“The highly-anticipated Cobra Reduce trial aims to expand upon the Shield study’s exceptional clinical results and demonstrate Cobra PzF NCS as a safe and effective stent option when combined with 14-days of DAPT,” Dr. Donald Cutlip, executive director of the Baim Institute for Clinical Research, said. “I have many patients at high risk of bleeding or who have difficulty maintaining even short-term DAPT regimens. Being able to provide a therapy that is personalized to the patient is of great clinical value.”
“We are pleased that the Cobra PzF stent and the Cobra Reduce trial are part of the important DAPT discussion taking place at the upcoming TCT conference,” CEO Jason Cone added. “Results from this first-of-its-kind study will offer insight into how CeloNova can further improve individualized care and optimize outcomes in this patient population.”