Abbott Vascular Devices, a division of Abbott Laboratories, announced the enrolment of the first patient in the Zomaxx I drug-eluting coronary stent clinical trial.
Zomaxx I is a 400-patient prospective randomized clinical trial that will be conducted in more than 30 centres in Europe, Australia and New Zealand. The study compares Abbott's ZoMaxx drug-eluting coronary stent to Boston Scientific's Taxus Express drug-eluting stent with a primary endpoint of 9-month in-segment late loss (a measurement of the re-narrowing of the vessel). Enrolment is expected to continue through the first quarter of 2005, an official statement said.
"The initiation of the Zomaxx I clinical trial represents a significant milestone for our organization," said Robert B Hance, president, Abbott Vascular Devices. "Along with our plans for a North American pivotal trial, the start of Zomaxx I demonstrates our commitment to becoming a leading player in drug-eluting stents, one of the fastest growing areas in medical technology," he added.
Robert Whitbourn of St. Vincent's Hospital in Melbourne, Australia, enrolled the first patient in the Zomaxx I trial. "I am looking forward to enrolling additional patients in this important trial. Based on in vitro studies, the ZoMaxx stent design demonstrated excellent flexibility, contributing to a high level of deliverability. I am eager to test the device clinically," said Dr. Whitbourn.
The ZoMaxx stent used in this study consists of three key components: the drug, the stent platform and the polymer carrier. The drug, ABT-578, is a patent-protected immunosuppressant discovered and synthesized by Abbott scientists. It inhibits inflammation and proliferation of smooth muscle cells, both key targets in treating restenosis (the re-narrowing of the artery after an interventional procedure).
The second key component for ZoMaxx is the underlying stent platform - the TriMaxx Coronary Stent, which is currently under CE Mark review as a non-drug eluting stent. The TriMaxx stent is anticipated to be the next evolution in metallic stents with its unique tri-layer composite of stainless steel and tantalum, and its ultra-low crossing profile - designed to facilitate placement of the stent in the artery.
The third key component of the ZoMaxx stent is Pharmacoat, a unique formulation of phosphorylcholine polymer coating licensed to Abbott from Biocompatibles International plc. Phosphorylcholine is a polymeric replica of the outer surface of a red blood cell that acts as a biologically inert coating that resists clot formation in vitro.
The principal investigator of Zomaxx I, Bernard Chevalier of Centre Cardiologique Nord, near Paris, France, said, "I am delighted to be associated with this important clinical study. Abbott Vascular Devices has worked to optimize all of the key components in its drug-eluting stent technology. The drug, ABT-578, is a promising compound in the battle against restenosis, and the phosphorylcholine polymer, Pharmacoat, is formulated to provide a slow, controlled release of the drug. By randomizing against Taxus, the Zomaxx I trial will demonstrate the performance of the ZoMaxx stent."