Essentials of Clinical Trial Design: Statistics 101 for the Budding Interventionalist
Positive results from the landmark PzF SHIELD IDE clinical trial reinforce safe and effective use in a real-world clinical practice of the world's first non-drug-eluting, nanocoated coronary stent.
"It's truly remarkable to have a stent achieve complete protection from ischemic events with 0% definite and probable stent thrombosis at both the 9-month and 5-year follow-up periods," said Prof. Sigmund Silber, MD, PhD, Professor of Medicine FESC, FACC, FAHA at Practice in the ISAR Heart Center in Munich, Germany. "The results are particularly noteworthy given the highly complex nature of the patients who were studied. It offers valuable insight into COBRA's performance as coronary artery disease progresses over time."
A total of 296 patients with de novo coronary artery lesions from 35 centers across the U.S. and Europe received treatment with COBRA PzF NCS in the single-arm, non-randomized trial. The study's population included elderly patients (66.5 average age) with co-morbidities including diabetes (33.7%), atrial fibrillation (12.2%) and those with highly complex lesions (72% with type B2 or C lesions).
"These results reinforce the unique thromboresistant, anti-inflammatory and rapid healing properties of COBRA's proprietary Polyzene-F coating, which has been consistently demonstrated in my pre-clinical research at CVPath since 2012," stated Aloke Finn, MD, Medical Director and Chief Scientific Officer at CVPath and Associate Professor of Medicine at the University of Maryland. "The results of the SHIELD trial show that there is a unique advantage of the Polyzene-F coating in allowing a stent to heal quickly and in a functional way without the need for antiproliferative drug elution. I believe COBRA will continue to play an important role in delivering safety and efficacy in real-world clinical practice over time."
Over 25,000 patients worldwide have been treated to date with COBRA PzF NCS. The novel stent has been extensively evaluated over the course of 10 years and 10 clinical trials in roughly 3,300 patients worldwide, consistently demonstrating excellent results with exceptionally low ST, low TLR and with short DAPT regimens in a real-world patient population.4
"We are extremely pleased that COBRA PzF NCS continues to strike the perfect balance between safety and efficacy and proud of its durable long-term clinical outcomes," stated Carl St. Bernard, President and Chief Executive Officer of CeloNova. "We look forward to continuing to evaluate its performance with ultra-short DAPT in the highly underserved patient population at high risk for bleeding."
COBRA PzF NCS is currently being evaluated with 14-days DAPT in high bleeding risk patients in the COBRA REDUCE clinical trial, the world's first and only randomized, global 14-day DAPT study. The study's six-month results, which were announced at TCT 2020, demonstrated strong ischemic performance of 0.6% definite and probable ST with just 14 days of DAPT with COBRA PzF NCS.† The company anticipates release of the study's 12-month results later this year.
About CeloNova BioSciences, Inc.
CeloNova BioSciences, Inc. is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene-F nanocoating technology. The next generation nanocoating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date. For additional information about CeloNova, please visit our website at www.celonova.com.