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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT02407457
First received: March 6, 2015
Last updated: February 1, 2016
Last verified: January 2016
  Purpose
The objective of this post-market study 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 study to include a broad range of experience. Imaging data will be evaluated by an independent core lab.

Condition Intervention Phase
Abdominal Aortic Aneurysm
Device: AFX EVAR AAA Graft System
Device: FDA Approved EVAR AAA Graft Systems
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Endologix:

Primary Outcome Measures:
  • Absence of Aneurysm Related Complications (ARC) [ Time Frame: five years ]

Secondary Outcome Measures:
  • MAEs [ Time Frame: at 30 days, 12 months, and annually up to five years ]

Estimated Enrollment: 800
Study Start Date: March 2015
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AFX EVAR AAA Graft System
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
Device: AFX EVAR AAA Graft System
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
Active Comparator: FDA Approved EVAR AAA Graft Systems
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
Device: FDA Approved EVAR AAA Graft Systems

Detailed Description:

This study is a prospective, randomized, multi-center study, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The study 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 AAA and eligible for endovascular Abdominal Aortic Aneurysm Repair

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02407457

Locations
United States, Mississippi
North MS Medical Center
Tupelo, Mississippi, United States, 38801
Sponsors and Collaborators
Endologix
Investigators
Study Director: Avyava Sharma Endologix
  More Information

Publications:

Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT02407457     History of Changes
Other Study ID Numbers: CP-0011
Study First Received: March 6, 2015
Last Updated: February 1, 2016

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on March 28, 2017