ECLIPSE Trial of CSI's Orbital Atherectomy System Begins Enrollment
March 28, 2017—Cardiovascular Systems, Inc. (CSI), in partnership with the Cardiovascular Research Foundation, announced the commencement of enrollment in the ECLIPSE clinical trial that will evaluate CSI's Diamondback 360 coronary orbital atherectomy system (OAS).
ECLIPSE is a prospective, multicenter, randomized clinical trial that will enroll approximately 2,000 patients with severely calcified coronary lesions in the United States. Half the participants will undergo orbital atherectomy before drug-eluting stents (DES) implantation. The other half of participants will undergo conventional angioplasty, including the use of specialty balloons, followed by DES implantation.
According to the company the trial is powered to demonstrate differences in the primary endpoints of postprocedural 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 1 year. ECLIPSE will also evaluate key health economic outcomes.
The company noted that approximately 12% of coronary lesions are calcified, and current estimates suggest that atherectomy is only used in approximately 3% of coronary interventions.
Ajay Kirtane, MD, who is a Principal Investigator of the ECLIPSE trial, commented in CSI's announcement, “Many of us feel that coronary atherectomy is underutilized, particularly given the increasing complexity of lesions and patients seen in current-day interventional practice. ECLIPSE is the largest randomized clinical trial to date expressly designed to assess the utility of adjunctive coronary atherectomy for calcific coronary artery disease.” Dr. Kirtane is the Director of the Cardiac Catheterization Laboratories at New York-Presbyterian/Columbia University Irving Medical Center in New York, New York.
ECLIPSE Coprincipal Investigator Philippe Généreux, MD, stated, “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 coronary artery disease.” Dr. Généreux is an interventional cardiologist at Morristown Medical Center, New Jersey, and Director of the Angiographic Core Laboratory at the CRF Clinical Trials Center.
The first patient in the trial was treated by Richard Shlofmitz, MD, who commented in the company's announcement, "Severely calcified coronary lesions have continued to grow in complexity while treating coronary artery disease. The Diamondback 360 coronary 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." Dr. Shlofmitz is an interventional cardiologist and Director of the Department of Cardiology at St. Francis Hospital in Roslyn, New York.