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TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe — LUCY  

Abdominal Aortic Aneurysm Clinical Trial

Official title:
The LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02703428
Study type Observational
Source Endologix
Contact
Status Completed
Phase
Start date February 2016
Completion date May 2019
View Details
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