News | Atherectomy Devices | April 04, 2017

Cardiovascular Systems Enrolls First Subject in ECLIPSE Coronary Clinical Trial

Trial compares treatment strategies for patients with severely calcified coronary arteries

Cardiovascular Systems Inc., CSI, ECLIPSE clinical trial, Diamondback 360 Coronary Orbital Atherectomy System, first subject enrolled

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:

Related Content

Medtronic Receives FDA Clearance for Riptide Aspiration System
Technology | Atherectomy Devices | January 16, 2018
Medtronic plc announced the company’s Neurovascular business unit received U.S. Food and Drug Administration (FDA)...
Avinger Announces Treatment of First Patients With Next-Generation Pantheris
News | Atherectomy Devices | January 09, 2018
January 9, 2018 – Avinger Inc. announced that Arne Schwindt, M.D., a vascular surgeon at St.
Avinger Receives 510(k) Clearance for Pantheris Image-Guided Atherectomy Device Modifications
Technology | Atherectomy Devices | November 20, 2017
November 20, 2017 — Avinger Inc. announced in October that the company received 510(k) clearance from the U.S.
Avinger Receives CE Mark for In-Stent Restenosis Indication With Pantheris Image-Guided Atherectomy
Technology | Atherectomy Devices | September 29, 2017
Avinger Inc. recently announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the...
Ra Medical Systems Receives FDA Clearance for New Peripheral Artery Disease Treatment
Technology | Atherectomy Devices | May 30, 2017
The U.S. Food and Drug Administration (FDA) announced that it has granted market clearance to Ra Medical Systems for...
CSI recall for saline pump on its atherectomy system
News | Atherectomy Devices | April 19, 2017
Cardiovascular Systems Inc. (CSI) announced April 18 it had initiated a voluntary recall of its 7-10014 Saline Infusion...
CSI, LIBERTY 360 Study, ISET 2017, six-month data, lower extremity PAD
News | Atherectomy Devices | February 08, 2017
February 8, 2017 — Cardiovascular Systems (CSI) presented six-month data from its LIBERTY 360° post-market study in a
Avinger, VISION Study, two-year outcomes, LINC, Lumivascular technology, Pantheris, OCT-guided atherectomy
News | Atherectomy Devices | February 03, 2017
Avinger Inc. recently announced positive two-year clinical data from the pivotal VISION study of the company’s...
Overlay Init