News | Stents | October 27, 2017

FDA Approves COBRA REDUCE Trial Expansion

Trial will assess safety and efficacy of Cobra PzF NanoCoated Coronary Stent with 14-day DAPT in high bleeding risk patients

FDA Approves COBRA REDUCE Trial of 14-Day DAPT With CeloNova Stent

October 27, 2017 — CeloNova BioSciences Inc. announced the U.S. Food and Drug Administration (FDA) approved expansion of CeloNova's ongoing clinical trial of its proprietary Cobra PzF NanoCoated Coronary Stent (NCS) with 14-day dual antiplatelet therapy (DAPT) in complex patients, such as those who are at high bleeding risk. The COBRA REDUCE trial is the world's first and only randomized control trial to assess 14-day DAPT after percutaneous coronary intervention (PCI), according to the company.

"High-bleeding-risk patients currently have limited stent treatment options available to them primarily due to the duration of DAPT required," stated Robert Byrne, M.D., senior physician at the German Heart Center in Munich, Germany and co-lead investigator of the COBRA REDUCE trial. "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 COBRA REDUCE trial is evaluating whether Cobra PzF NCS with its ultra-pure, ultra-thin Polyzene-F (PzF) fluoropolymer can optimize clinical outcomes with 14-day DAPT as compared to FDA-approved drug-eluting stents (DES) with three or six months of DAPT. The COBRA REDUCE trial will enroll up to 996 patients across 60 centers in the United States and Europe. Clinical data from CeloNova's previous trial, the PzF SHIELD study, demonstrated that Cobra PzF NCS supports very low risk for late ischemic events and low risk for clinically driven total lesion revascularization (TLR) with a short, one-month DAPT minimum.[1,2]

"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," said Donald Cutlip, M.D., executive director of the Baim Institute for Clinical Research (formerly Harvard Research Institute). "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." 

Cobra PzF NCS and the COBRA REDUCE trial will be featured in several sessions at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference, Oct. 29-Nov. 2, 2017, in Denver. 

For more information: www.celonova.com

 

References: 

1. Cutlip D, Garrat K, Novack V, et al. 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC Cardiovasc Interv. 2017;10(2):160-167.

2. Levine G, Bates E, Bittl J, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease. Circulation. 2016;134(10):e123-55.

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