The LUCY Study: TriVascular Evaluation of Females Who Are
Underrepresented Candidates for Abdominal Aortic Aneurysm Repair
SPONSOR: Trivascular, Inc. / Endologix
PI: Robert Meisner, MD
CRC: Susan Herring, MEd, BSN, RN | 484.476.8514
The LUCY Study is a prospective, consecutively enrolling, non-randomized
multi-center post-market registry to evaluate the low profile Ovation®
Abdominal Stent Graft Platform when used in the treatment of female
patients with endovascular disease. The primary endpoint is the Major
Adverse Event rate within 30 days of the initial procedure. The
secondary endpoint of the study is to demonstrate the benefits in female
patients (Treatment group) are comparable to male patients (Control
Group) despite the fact that historically fewer female patients have
been eligible for endovascular aortic repair, and they have experienced
a higher rate of access related complications and higher mortality
rates. Secondary endpoints will be evaluated through one year
post-procedure. Both men and women who are considered to be a candidate
for elective open surgical repair of an abdominal aortic aneurysm may be
candidates to participate.
For additional information on cardiovascular clinical
trials, please call Ann Marie Chikowski, BSN, RN, CCRC, Clinical
Research Manager at 484.476.3030.
For more information, call 1.866.CALL.MLH.