Cardiovascular Systems has announced the design of a new clinical trial comparing the company’s Diamondback 360 coronary orbital atherectomy system versus conventional angioplasty, including specialty balloons, for vessel preparation prior to drug-eluting stent implantation.
The clinical trial consists of up to 2,000 subjects at up to 60 sites in the U.S. Half the participants will receive orbital atherectomy prior to DES implantation, while the other half will receive conventional angioplasty, including specialty balloons, followed by DES implantation.
The goal is for the trial to demonstrate differences in the primary endpoints of post-procedural minimal cross-sectional area (assessed by intravascular imaging in a subset of up to 400 patients) as well as in the clinical outcome of target vessel failure at one year.
The trial is expected to begin recruiting in spring 2017. — Cynthia Jessup