The study will be done in collaboration with Cardiovascular Research Foundation to compare CSI’s Diamondback 360 coronary orbital atherectomy system (OAS) against conventional angioplasty, including specialty balloons, for vessel preparation prior to drug-eluting stent (DES) implantation.
ECLIPSE trial is a prospective, multi-center and randomized clinical study, which will recruit up to 2,000 subjects at around 60 sites in the US.
Half the participants will secure orbital atherectomy prior to DES implantation, while the other half will receive conventional angioplasty, including specialty balloons, followed by DES implantation.
According to the firm, the study will show differences in the primary endpoints of post-procedural minimal cross-sectional area, as well as in the clinical outcome of target vessel failure at one year.
The company intends to start the trial in the spring of next year.
In 2013, the Diamondback 360 coronary OAS secured approval from the US Food and Drug Administration (FDA) to treat severely calcified coronary arteries.
The trial’s co-principal investigator Dr Ajay Kirtane said: “The ECLIPSE trial reflects the growing complexity of coronary artery disease (CAD) seen in the modern-day cardiac catheterization laboratory, and will be the largest randomized clinical trial to date to assess the use of adjunctive coronary atherectomy for calcific coronary artery disease.”
The trial’s co-principal investigator Dr Philippe Généreux said: “Coronary calcification has been shown to increase procedural complexity and adverse events following conventional percutaneous coronary intervention (PCI).”
