Brief Title
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Official Title
Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
Brief Summary
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.
Detailed Description
This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups. Randomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses. Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.
Study Type
Interventional
Primary Outcome
Number of Patients With Absence of Aneurysm Related Complications (ARC)
Secondary Outcome
The Number of MAEs
Condition
Abdominal Aortic Aneurysm
Intervention
AFX EVAR AAA Graft System
Study Arms / Comparison Groups
AFX EVAR AAA Graft System
Description: Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
455
Start Date
March 2015
Completion Date
September 2022
Primary Completion Date
October 2018
Eligibility Criteria
Inclusion Criteria: 1. Male or female at least 18 years old 2. Subjects with minimum of 2 year life expectancy 3. Subjects have signed the informed consent document for data release 4. Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices. Exclusion Criteria: 1. Currently participating in another study where primary endpoint has not been reached yet 2. Known allergy to any of the device components 3. Pregnant (females of childbearing potential only) 4. Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Christopher Kwolek, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02407457
Organization ID
CP-0011
Responsible Party
Sponsor
Study Sponsor
Endologix
Study Sponsor
Christopher Kwolek, MD, Principal Investigator, Endologix
Verification Date
November 2021