NOBORI 1 is a prospective, randomized clinical trial that will enrol 360 patients in 30 centres in Europe, Australia and Asia. The NOBORI 1 is an equivalency study that will compare Terumo's Nobori™, Biolimus A9 drug-eluting stent to Boston Scientific's Taxus™ Express2™ drug-eluting stent in an un-proportional 2:1 design. The primary endpoint is 9-month in-stent late loss. Secondary endpoints include Angiographic Binary Restenosis, Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR) and Target Vessel Failure (TVF) rates at nine months, Major Adverse Cardiac Events (MACE) at 30 days, 4, 9 and 12 months and annually up to five years, Stent thrombosis at 30 days and 9 months, Lesion, Device and Procedure success. The principal Investigator of the study is Bernard Chevalier MD. of Centre Cardiologique Nord, near Paris, France.
Dr. Sianos of Erasmus University Hospital in Rotterdam enrolled the first patient in NOBORI 1 clinical trial during live case transmission at EuroPCR05. "I am very pleased to implant first Nobori™ stent which showed excellent performance in this difficult case and I am looking forward to see the results of this study which are expected to match the exceptional findings of the first clinical trial with Biolimus A9 eluting stent, the STEALTH study" said Dr Sianos.
Dr Bernard Chevalier, Principal Investigator of the NOBORI 1 study expressed great enthusiasm for the launch of this first head-to-head comparison DES trial involving a bioabsorbable polymer.
"The initiation of the NOBORI 1 clinical trial represents a significant milestone for our Company," said Yutaro Shintaku, President, Terumo Corporation, Interventional Systems Company. "We are confident that this trial will successfully meet its endpoints, and that with Nobori™, drug eluting stent, cardiologists will have the valuable alternative for the treatment of the patients with coronary artery disease."
The Nobori™ stent used in this study consists of three key components: the drug, the stent platform and the polymer carrier. The Biolimus A9™, is an immunosuppressive drug specifically developed for stent application by the scientist of Biosensors International, company with which Terumo Corporation signed an alliance agreement for the co-development and distribution of drug eluting stent. The Biolimus A9™ has been shown in preclinical and clinical testing to inhibit smooth muscle cells proliferation and restenosis.
The bare stent platform is S-Stent a corrugated ring stent, which combines repeating S symmetry and very short segment lengths to provide excellent flexibility and high vessel wall support in both straight and curved vessels. The flexibility of S-stent allows it to be placed even into tortuous vessels, and enhances conformability with the blood vessel after implantation. The S-Stent was specifically designed with a uniform and repeating pattern in order to achieve the objective of uniform drug distribution in the vessel wall as drug is released from the stent struts.
The drug carrier is poly-lactic acid (PLA) a biodegradable polymer that degrades primarily by hydrolysis and the degradation product is water soluble lactic acid. It gets absorbed by tissue and is eventually converted to water and carbon dioxide.
Drug/Polymer matrix is coated exclusively on the outside, abluminal surface of the stent, decreasing as such systemic expose of the patients to the drug, and targeting specifically vessel wall tissue.
Terumo Corporation, Tokyo, Japan, is a premier global medical company with 2004 $ 2.14 billion annual sales (¥ 230 billion) and TERUMO Europe N.V. is an affiliate of the company in Europe. Terumo Corporation develops, manufactures, and markets a wide range of medical products including cardiovascular systems, disposable medical devices, therapeutic catheters, I.V. solutions, blood bags, diabetes care systems, and medical electronic products in more than 160 countries.