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 endovascular treatment of female patients.
The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the Ovation Abdominal Stent Graft Platform when used in the endovascular treatment of female patients. The primary endpoint is the Major Adverse Event (MAE) rate within 30 days of the initial procedure. MAEs will be adjudicated and reported based upon an independent Clinical Events Committee (CEC). Secondary endpoints of the study will be achieved by demonstrating 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 EVAR, and they have experienced a higher rate of access-related complications and higher mortality rates. Secondary endpoints will be evaluated through 1 year (365 ± 60 days) post-procedure. A maximum of 45 sites across the United States are expected to enroll 225 subjects (75 females in the Treatment Group and 150 males in the Control Group).
Study Type
OBSERVATIONAL
Enrollment
225
Stanford University
Stanford, California, United States
Major Adverse Event (MAE)
Time frame: 1 month (30 ± 10 days)
Serious and Non-Serious Adverse Events
Time frame: 1 year (365 ± 60 days)
Access-related vascular complications
Time frame: 1 year (365 ± 60 days)
Technical (deployment) success
Time frame: 1 year (365 ± 60 days)
Freedom from Type I & III endoleaks
Time frame: 1 year (365 ± 60 days)
Freedom from migration
Time frame: 1 year (365 ± 60 days)
Freedom from aneurysm enlargement
Time frame: 1 year (365 ± 60 days)
Freedom from AAA rupture
Time frame: 1 year (365 ± 60 days)
Freedom from conversion to open repair
Time frame: 1 year (365 ± 60 days)
Freedom from AAA related secondary interventions
Time frame: 1 year (365 ± 60 days)
Freedom from mortality (all cause and AAA related)
Time frame: 1 year (365 ± 60 days)
Clinical Utility, including:
Blood loss, including if transfusion required, Duration of procedure, Length of hospital and ICU (if required) stay, Anesthesia type
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Time frame: 1 year (365 ± 60 days)