The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market study to evaluate the low profile (14F) 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 study to evaluate the Ovation Abdominal Platform when used in the endovascular treatment of female patients. The primary endpoint is freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days. Secondary endpoints of the study will be achieved by demonstrating the benefits in female patients 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.
Study Type
OBSERVATIONAL
Enrollment
30
OLV Ziekhenuis
Aalst, Belgium
UZ Leuven
Leuven, Belgium
HGZ Bad Bevensen
Bad Bevensen, Germany
August Krankenhaus
Düsseldorf, Germany
Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days.
Time frame: 30 ± 10 days
Serious and Non-Serious Adverse Events
Time frame: 365 ± 60 days
Access-related vascular complications
Time frame: 365 ± 60 days
Technical (deployment) success
Defined as successful delivery and deployment of one aortic body and at least two iliac limbs.
Time frame: 365 ± 60 days
Freedom from Type I & III endoleaks
Time frame: 365 ± 60 days
Freedom from migration
Time frame: 365 ± 60 days
Freedom from aneurysm enlargement
Time frame: 365 ± 60 days
Freedom from Abdominal Aortic Aneurysm rupture
Time frame: 365 ± 60 days
Freedom from conversion to open repair
Conversion to open surgical repair occurs when a subject implanted with an Ovation Abdominal Platform undergoes open surgical repair with explantation of the stent graft.
Time frame: 365 ± 60 days
Freedom from AAA related secondary interventions
Time frame: 365 ± 60 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Düsseldorf
Düsseldorf, Germany
University Medical Center Hamburg
Hamburg, Germany
Hospital Karlsruhe
Karlsruhe, Germany
University of Leipzig
Leipzig, Germany
Institute of Hematology and Blood Transfusion
Warsaw, Poland
Bedfordshire Hospitals NHS Trust
Bedford, United Kingdom
Freedom from mortality (all cause and AAA related)
Time frame: 365 ± 60 days
Blood Loss
Estimate blood loss and replacement requirements, (e.g. transfusion).
Time frame: 365 ± 60 days
Duration of Procedure
Time enter procedure room, time start arterial access, stent graft deployment start and stop time, time of closure of arterial access, and time exit procedure room.
Time frame: 365 ± 60 days
Length of hospital and ICU (if required)
Time frame: 365 ± 60 days
Anesthesia Type
Time frame: 365 ± 60 days