Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 800
Summary
- Conditions
- Abdominal Aortic Aneurysm
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02407457
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Christopher Kwolek, MD Endologix
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