Enrollment Begins in TriVascular's LUCY Study

August 24, 2015—TriVascular, Inc. announced that the first patient was enrolled and treated in the LUCY study, which seeks to study endovascular aneurysm repair (EVAR) in women, who are underrepresented candidates for abdominal aortic aneurysm (AAA) repair. 

According to TriVascular, the LUCY study is a prospective, consecutively enrolling, nonrandomized multicenter postmarket registry designed to evaluate the company’s ultra-low-profile (14-F) Ovation abdominal stent graft platform when used in the endovascular treatment of AAA in women compared to men. 

The primary objective of the LUCY study is to demonstrate the clinical outcomes and benefits associated with using the Ovation abdominal stent graft platform in both women and men, including low rates of access-related vascular complications, low mortality rates, and high eligibility rates, even in patients who tend to have small access vessel diameters and challenging aortic neck anatomy. The study will enroll up to 225 subjects (75 women in the treatment group and 150 men in the cntrol group) in up to 45 sites in the United States. The study results will provide a comparison of outcomes between women and men. The primary endpoint is the major adverse event rate within 30 days of the initial procedure.

The company noted that the lack of adequate treatment options, principally because of suboptimal, large-bore, conventional EVAR systems, is a persistent issue for female AAA patients. Clinical literature shows that women diagnosed with AAA experience aortic expansion at a rate that is 40% to 80% faster than men, which can result in aortic rupture at smaller diameters. On average, women with AAAs have challenging access vessel anatomy and, often, hostile aortic neck anatomy. This, combined with the technical limitations of conventional stent graft systems, results in significantly decreased access to on-label EVAR treatment for most women.

The first patient in the LUCY study was treated by Krishna Mannava, MD, and Omar Al-Nouri, DO, at Fairfield Medical Center in Lancaster, Ohio. Dr. Mannava commented in the company’s press release, “We are excited to participate in this important study. The Ovation system is ideally suited for patients with small-diameter access vessels and diseased aortic necks, which is often characteristic of female patients. Our first LUCY case went well and we are excited to continue enrolling and, ultimately, see the results from this landmark study.”

The LUCY study advisory board is led by Chair Jennifer Ash, MD. Dr. Ash is with the Christie Clinic Vein & Vascular Center and Assistant Clinical Professor of Surgery University of Illinois College of Medicine in Champaign, Illinois. Dr. Ash commented, “Women have traditionally been underrepresented in EVAR clinical trials despite a distinct need to increase patient eligibility and identify appropriate gender-specific treatment algorithms. I am excited to be a part of the LUCY study which is designed to provide information that has been lacking for physicians and patients on the benefits of EVAR for women.”

In addition to Dr. Ash, the LUCY study advisory board includes Venita Chandra, MD, Clinical Assistant Professor, Surgery-Vascular Surgery Stanford School of Medicine in Stanford, California; Monica Hunter, MD, Ohio Heart and Vascular Center and Director, Critical Limb Ischemia Program at The Christ Hospital in Cincinnati, Ohio; Eva M. Rzucidlo, MD, Associate Professor of Surgery, Geisel School of Medicine at Dartmouth College in Lebanon, New Hampshire; and Ageliki Vouyouka, MD, Associate Professor Surgery and Radiology, at Mount Sinai Hospital in New York, New York.