Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices

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Abdominal aortic aneurysm
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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