NCT02479191

LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 225 (actual)
• Sponsor: TriVascular, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Ovation Abdominal Stent Graft Platform

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-05-01
• Completion: 2019-09-30
• First posted: 2015-06-24
• Last updated: 2021-06-01

Locations

1 site across 1 country: United States