The first patient has been enrolled in CeloNova BioSciences’ COBRA REDUCE trial, which will study the Cobra PzF nanocoated coronary stent system in patients at a high risk of bleeding. The trial recently received conditional US Food and Drug Administration (FDA) approval.
The first stent in the trial was implanted at the Northshore University Hospital, New York, USA by Loukas Boutis. Eventually, 844 patients will be enrolled in the clinical trial both in the USA and Europe.
Rajiv Jauhar, chief of Cardiology and director of Cardiac Catheterization Labs at the Northshore University Hospital in New York, says, “We are excited to be part of this second, very important, trial with the COBRA PzF stent. We were the highest enrolling centre in the initial PzF SHIELD trial with the COBRA PzF stent and hope to repeat our achievement.”
The trial will evaluate if the Cobra PzF stent, with its novel Polyzene-F nanocoating and advanced thin-strut design, can help reduce bleeding as compared to drug-eluting stents (DES), by shortening the duration of dual antiplatelet therapy (DAPT) to 14 days in patients treated with oral anticoagulation and undergoing PCI.
“For patients with high risk of bleeding such as those on triple therapy, the optimal duration of DAPT and type of stent are important questions,” says Adnan Kastrati, professor of Medicine at Deutsches Herzzentrum, München, Germany and the principal investigator of the trial.
”If the Cobra PzF stent, with its novel nanocoating, is able to reduce the duration of DAPT to only two weeks and to reduce bleeding, while maintaining parity with DES in thrombosis and restenosis, it could be a very compelling new treatment option.”
The COBRA REDUCE trial is the second major interventional cardiology trial for CeloNova and follows a successful early enrolment completion of the PzF SHIELD investigational deviced exemption study last year. Positive results from the PzF SHIELD study would allow the company to complete its pre-marked approval application to the FDA for the Cobra PzF stent. These trials are part of a comprehensive clinical program studying over 2000 patients worldwide. Previous peer-reviewed studies with over 700 patients implanted with the prior generation stent coated with the Polyzene-F nanocoating demonstrated low TLR and no stent thrombosis.
The Cobra PzF stent has thin struts made of Cobalt Chromium Super Alloy and is coated with an advanced Polyzene-F nanocoating, which may reduce fibrinogen and platelet adhesion as shown in preclinical studies. Furthermore, the stent platform is designed to minimise vessel wall injury and lower inflammation as demonstrated in preclinical studies, according to a company release.
The Cobra PzF coronary stent system is an investigational device in the United States. The Cobra PzF coronary stent system received CE mark approval in 2012 and launched in Europe and the Middle East in 2013.