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

Related Content

Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab | November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Overlay Init