Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced today that the first patient has been enrolled in the CYPRESS study, which will assess clinical outcomes in a broad range of patients with coronary artery disease who take dual anti-platelet therapy after receiving a CYPHER® Sirolimus-eluting Coronary Stent. The procedure was performed by Patrick Flaherty, D.O., Arkansas Heart Hospital in Little Rock, AK.
CYPRESS will provide data to support the clinical evaluation of the company’s new NEVO™ Sirolimus-eluting Coronary Stent in the NEVO III trial, a non-randomized, single-arm trial evaluating the clinical outcomes of NEVO™ in approximately 1,200 patients in the United States and Canada. NEVO™ is the first drug-eluting stent utilizing RES TECHNOLOGY™, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. Products using RES TECHNOLOGY™ are under development and are not approved or available for sale in any market.
“While the original clinical trials of the CYPHER® Stent have demonstrated sustained efficacy and similar safety to bare-metal stents through five years of follow-up, many technical improvements in percutaneous coronary interventions and concomitant therapy may lead to even better outcomes with the world’s most studied drug-eluting stent,” said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation.
Dr. Rogers continued, “CYPRESS will be used to support our pre-market approval application in the U.S. for NEVO™, which we believe has the potential to return Cordis to global leadership in the drug-eluting stent market.”
CYPRESS will enroll an estimated 2,000 patients at approximately 200 centers throughout the U.S. The patients in this study will represent a variety of coronary artery disease cases including those considered ‘complex’ due to multi-vessel disease.
In addition, clinical data from CYPRESS (CYPherR for Evaluating Sustained Safety) will contribute to the approximately 20,000-patient independent Dual Antiplatelet Therapy (DAPT) Study, a unique collaboration amongst the U.S. Food and Drug Administration, drug and device manufacturers and Harvard Clinical Research Institute. The DAPT Study concept was developed by a group of stent manufacturers and manufacturers of antiplatelet medications who came together to address a FDA request for this post-market study. The Harvard Clinical Research Institute is responsible for the scientific conduct and independent analysis of the overall study.
The CYPRESS trial is divided into two phases. In Phase I, patients will receive the CYPHER® Stent and receive 12-months of dual antiplatelet therapy with a thienopyridine - clopidogrel or prasugrel - and aspirin. The primary endpoint of this portion of the trial is target lesion failure at 12-months.