Cardiovascular Systems has announced the complete enrolment of its 2,000-patient ECLIPSE coronary trial.
ECLIPSE is a prospective, multicentre, randomised clinical trial of approximately 2,000 patients with severely calcified coronary lesions in the USA. Half of the participants received orbital atherectomy prior to drug-eluting stent implantation, while the other half received conventional angioplasty, including specialty balloons, followed by drug-eluting stent (DES) implantation.
The trial is powered to demonstrate differences in the primary endpoints of post-procedural in-stent minimal cross-sectional area (assessed by optical coherence tomography (OCT) imaging in a subset of approximately 400 patients), as well as in the clinical outcome of target vessel failure at one year. ECLIPSE will also evaluate key health economic outcomes.
Results from ECLIPSE are expected to be shared in late 2024.
Jeffrey W Chambers, CSI’s chief medical officer, said: “ECLIPSE is important because it tests two treatment strategies for managing one of the most difficult challenges for interventional cardiologists. We believe the data from this study will be beneficial in defining an optimal treatment plan for patients with severely calcified coronary arteries.”
