Expired Study
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Tupelo, Mississippi 38801


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.


Study summary:

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.


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)


NCT ID:

NCT02407457


Primary Contact:

Study Director
Avyava Sharma
Endologix


Backup Contact:

N/A


Location Contact:

Tupelo, Mississippi 38801
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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