TriVascular Technologies, Inc. (NASDAQ:TRIV), manufacturer of the Ovation® Abdominal Stent Graft platform, announced today the first patient enrolled and treated in the LUCY Study (TriVascular Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair).
The first LUCY Study patient was treated by Krishna Mannava, MD and Omar Al-Nouri, DO at Fairfield Medical Center in Lancaster, Ohio. The LUCY study is a prospective, consecutively enrolling, non-randomized multi-center post-market registry designed to evaluate the ultra-low profile (14F) Ovation platform when used in the endovascular treatment of abdominal aortic aneurysms (AAA) in female as compared to male patients. The lack of adequate treatment options, principally due to 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 40-80% faster than men, which can result in aortic rupture at smaller diameters. On average, women with abdominal aortic aneurysms have challenging access vessel anatomy and, often, hostile aortic neck anatomy. This fact, when combined with the technical limitations of conventional stent graft systems, results in significantly decreased access to on-label EVAR treatment for most women.
“We are excited to participate in this important study,” stated Dr. Mannava. “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 is led by a five-physician advisory board, consisting of:
- Jennifer Ash, MD, Christie Clinic Vein & Vascular Center; and Asst. Clinical Prof. of Surgery University of Illinois College of Medicine in Champaign,
- Venita Chandra, MD, Clinical Assistant Professor, Surgery-Vascular Surgery Stanford School of Medicine,
- Monica Hunter, MD, Ohio Heart and Vascular Center and Director, Critical Limb Ischemia Program at The Christ Hospital,
- Eva M Rzucidlo, MD, Associate Professor of Surgery, Geisel School of Medicine, Dartmouth; and
- Ageliki Vouyouka, MD, Associate Professor Surgery and Radiology, Mount Sinai Hospital.
“Women have traditionally been under-represented in EVAR clinical trials despite a distinct need to increase patient eligibility and identify appropriate gender specific treatment algorithms,” said Dr. Ash, Chair of the LUCY Advisory Board. “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.”
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 female and male patients, including low 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 females in the Treatment Group and 150 males in the Control Group) in up to 45 sites in the United States. Study results will provide a comparison of female and male patient outcomes. The primary endpoint is the Major Adverse Event (MAE) rate within 30 days of the initial procedure.
“We are focused on developing products and providing clinical evidence to help expand EVAR access to more patients, and improve EVAR outcomes for all patients,” said Christopher G. Chavez, Chairman, CEO and President of TriVascular. “The goal of the LUCY Study is to answer very important questions and ensure that gender does not limit access to life-saving technology. We are excited to begin enrollment and are grateful to all of the study investigators who put their trust in our technology when caring for their patients.”
The Ovation platform has been used in the successful treatment of over 7,000 patients worldwide. Excellent clinical results have been reported from both the Ovation global pivotal trial and a 501-patient European Post-Market Registry. The Ovation platform is available for sale in over 35 countries.