Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices (LEOPARD)
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|ClinicalTrials.gov Identifier: NCT02407457|
Recruitment Status : Active, not recruiting
First Posted : April 3, 2015
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Device: AFX EVAR AAA Graft System Device: FDA Approved EVAR AAA Graft Systems||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||September 2022|
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
- The number of participants with Absence of Aneurysm Related Complications (ARC) [ Time Frame: 1 year ]
ARC is a composite of the most relevant EVAR outcomes and includes:
- Peri-Operative Death (< 30 days)
- Conversion to OSR
- Endoleaks; post-operative
- Migration (≥ 10mm)
- Aneurysm Enlargement (≥ 5mm)
- Endograft Limb Occlusions
- Reinterventions for device- or aneurysm-related complications
- The number of MAEs [ Time Frame: At 30 days, 12 months, and annually up to five years ]Major Adverse Events
- The number of Aneurysm Related Complications (ARC) [ Time Frame: Post 12 Months up to Five Years ]ARC is a composite outcome
- The Number of Participants with Aneurysm Related Mortality [ Time Frame: Up to Five Years ]Death related to the aneurysm
- Number of Endoleaks Classified by Type [ Time Frame: Up to Five Years ]All Endoloeaks
- Loss of Neck Apposition as measured by length in mm [ Time Frame: Up to Five Years ]Loss of Neck Apposition as measured by length in mm
- Number of AAA Related Secondary Procedures [ Time Frame: Up to Five Years ]Number of AAA related secondary procedures
- Number of Device integrity events [ Time Frame: Up to Five Years ]Number of device integrity events from device fractures and technical observations related to the stent graft
- Number of adjunctive procedures necessitated during the implant procedure. [ Time Frame: Up to Five Years ]Number of adjunctive procedures done during the implant procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407457
|United States, Mississippi|
|North MS Medical Center|
|Tupelo, Mississippi, United States, 38801|
|Principal Investigator:||Christopher Kwolek, MD||Endologix|