Endologix’s Ovation LUCY Study Completes Patient Enrollment
February 14, 2017—Endologix, Inc. announced that it has completed patient enrollment for the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) study. Per the company’s announcement, the study is a multicenter postmarket registry designed to explore the clinical benefits associated with endovascular aneurysm repair (EVAR) using the Ovation Abdominal Stent Graft Platform in female patients with abdominal aortic aneurysms as compared with men.
“Women have historically been underrepresented in EVAR clinical trials. One factor precluding women has been that traditional EVAR devices have been unable to accommodate the anatomic variances found in women, such as smaller access vessels and more challenging proximal aortic necks, compared to their male counterparts,” commented Venita Chandra, MD, a member of the study’s advisory board, in the company’s announcement. “The LUCY study is the first prospective study evaluating EVAR in a female population and it will make an important contribution to understanding the management and outcomes of women and other patients with similar anatomy.” Dr. Chandra is a Clinical Assistant Professor of Surgery-Vascular Surgery at Stanford School of Medicine in Stanford, California.
Endologix reported that the LUCY study enrolled a total of 225 patients, including 75 women in the treatment group and 150 men in the control group, at 39 sites in the United States. The primary endpoint of the study is the 30-day major adverse event rate.
Jennifer Ash, MD, chairperson of the study’s advisory board, also commented in the company’s announcement, “Retrospective analyses of women treated with traditional EVAR devices have consistently shown that women tend to have greater morbidity and mortality from EVAR intervention. Our preliminary analysis of the patients who have completed their 30-day follow-up visits suggests that women in the LUCY study derived similarly favorable benefits from the Ovation Platform’s ultra-low profile delivery system and unique proximal sealing ring as compared to their male counterparts.” Dr. Ash is a Vascular Surgeon at the Christie Clinic Vein and Vascular Center and an Assistant Clinical Professor of Surgery at the University of Illinois College of Medicine, in Urbana-Champaign, Illinois.
Dr. Ash added, “We look forward to completing the patient follow-up and presenting the analysis at an upcoming meeting.” The 30-day study results are anticipated to be presented at a medical meeting in the summer 2017.