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Trial record 4 of 34 for:    leopard

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:
ClinicalTrials.gov Identifier:
NCT02407457
First Posted: April 3, 2015
Last Update Posted: February 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Endologix
March 6, 2015
April 3, 2015
February 3, 2016
March 2015
September 2017   (Final data collection date for primary outcome measure)
Absence of Aneurysm Related Complications (ARC) [ Time Frame: five years ]
Same as current
Complete list of historical versions of study NCT02407457 on ClinicalTrials.gov Archive Site
MAEs [ Time Frame: at 30 days, 12 months, and annually up to five years ]
Same as current
Not Provided
Not Provided
 
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
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
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
  • Device: AFX EVAR AAA Graft System
    Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
  • Device: FDA Approved EVAR AAA Graft Systems
  • 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.
    Intervention: Device: AFX EVAR AAA Graft System
  • 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.
    Intervention: Device: FDA Approved EVAR AAA Graft Systems

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
800
September 2022
September 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02407457
CP-0011
No
Not Provided
Not Provided
Endologix
Endologix
Not Provided
Study Director: Avyava Sharma Endologix
Endologix
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP