Medtronic, Inc. (Medtronic), is planning to complete BRANCH trial for Bifurcation Stent by December 2009. The trial will assess the feasibility and safety of the Medtronic Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with reference vessel diameters (RVD) for the proximal main vessel of 3.8 - 4.3 mm, distal main branch of 3.0 - 3.5 mm, and side branch RVD up to 2.5 mm. The trial is being conducted in New Zealand.
The non-randomized, open label, uncontrolled, single group assignment, safety study is ongoing, but not recruiting participants. The study has estimated enrollment of 60 participants. The principal investigator of the study is Ian Meredith, MD Monash University.
Bifurcation stent employs Y-shaped design that would match the anatomy of lesions formed at the junctions of coronary arteries. The stent is delivered over a dual-wire delivery system through a single catheter. The stent works on balloon-tapering and folding technology. It is made of an advanced cobalt alloy, which enables the stent struts to be extremely thin while also providing sufficient strength to scaffold the artery. In addition, the stent features the same unique modular architecture and custom fusion laser pattern, which have shown deliverability, flexibility and conformability.
The official title of the trial is “The Medtronic Bare Metal Bifurcation Stent Clinical Trial in Humans.”