Endologix has completed patient enrolment in the Lucy (Evaluation of females who are underrepresented candidates for abdominal aortic aneurysm repair) study, a multicentre post-market 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 (AAA), as compared to males. It is the first prospective study evaluating EVAR in females, a population that has historically been underrepresented in EVAR clinical trials.
The Lucy study enrolled a total of 225 patients, including 75 females in the treatment group and 150 males in the control group, at US 39 sites. The primary endpoint of the study is the 30-day major adverse event rate. The 30-day results from the Lucy study are expected to be presented at a medical meeting in the summer of 2017.
Venita Chandra (Stanford School of Medicine, Stanford, USA), who is a member of the study’s advisory board, commented, “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. 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.”
Advisory board chairperson, Jennifer Ash (Christie Clinic Vein and Vascular Center and University of Illinois College of Medicine, USA) added, “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 suggest that women in the Lucy study derived similarly favourable benefits from the Ovation platform’s ultra-low profile delivery system and unique proximal sealing ring as compared to their male counterparts. We look forward to completing the patient follow-up and presenting the analysis at an upcoming meeting.”
John McDermott, chief executive officer of Endologix, said, “The completion of enrolment in the Lucy study is another important milestone in our efforts to continue building the clinical evidence in support of our innovative portfolio of AAA products. It highlights our commitment to developing technologies that can improve clinical outcomes for AAA patients, including populations such as women that have historically been underserved with existing technologies. I would like to thank the clinical investigators and trial sites for their participation and support of this important clinical study.”