April 4, 2017 — Cardiovascular Systems Inc., in partnership with the Cardiovascular Research Foundation (CRF), announced the first subject enrolled in its ECLIPSE clinical trial. The subject was treated by Richard Shlofmitz, M.D., interventional cardiologist and director of the Department of Cardiology at St. Francis Hospital, Roslyn, N.Y. Shlofmitz also treated subjects in CSI’s ORBIT II and COAST clinical studies.
"Severely calcified coronary lesions have continued to grow in complexity while treating coronary artery disease (CAD)," Shlofmitz said. “The Diamondback 360 Coronary Orbital Atherectomy System (OAS) provides a novel treatment option for these patients compared to conventional angioplasty. Definitive data from the ECLIPSE clinical trial will guide my treatment approach for these difficult-to-treat patients."
ECLIPSE is a prospective, multi-center, randomized clinical trial of approximately 2,000 subjects with severely calcified coronary lesions in the United States. Half the participants will receive orbital atherectomy prior to drug-eluting stent (DES) implantation, while the other half will receive conventional angioplasty, including specialty balloons, followed by DES implantation. The trial is powered 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. ECLIPSE will also evaluate key health economic outcomes.
“Many of us feel that coronary atherectomy is underutilized, particularly given the increasing complexity of lesions and patients seen in current-day interventional practice,” said Ajay Kirtane, M.D., director of the cardiac catheterization laboratories at New York-Presbyterian/Columbia University Irving Medical Center, and one of the principal investigators of the ECLIPSE trial. Approximately 12 percent of coronary lesions are calcified, and current estimates suggest that atherectomy is only used in approximately 3 percent of coronary interventions. Kirtane added, “ECLIPSE is the largest randomized clinical trial to date expressly designed to assess the utility of adjunctive coronary atherectomy for calcific CAD.”
Philippe Généreux, co-principal investigator of the trial, interventional cardiologist at Morristown Medical Center, N.J., and director of the Angiographic Core Laboratory at the CRF Clinical Trials Center, said, “Coronary calcification has been shown to increase procedural difficulty and adverse events following conventional percutaneous coronary intervention (PCI). The use of orbital atherectomy has the ability to significantly modify lesion morphology, enabling successful stent delivery to help optimize stent expansion and apposition. This supports why we are randomizing to conventional angioplasty, toward the goal of ultimately improving PCI outcomes. The value of this trial is that it will inform physicians regarding the most effective treatment protocols and strategies for treating patients with calcific CAD.”
CSI’s Diamondback 360 Coronary OAS received U.S. Food and Drug Administration (FDA) approval to specifically treat severely calcified coronary arteries in October 2013.
For more information: www.csi360.com