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Purpose

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult age 21 and older - Subjects with minimum of 2 year life expectancy - Subjects have signed the informed consent document - Subjects with unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices. - Patient must be able and willing to comply with all required follow-up exams.

Exclusion Criteria

  • Currently participating in another trial where the primary endpoint has not been reached yet. - Known allergy to any of the device components - Pregnant (females of childbearing potential only) - Known connective tissue disorders - Known active infection - Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR. - Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Alto Abdominal Stent Graft System 		Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.
  • Device: Alto Abdominal Stent Graft System
    Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
Active Comparator
Comparators 		Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.
  • Device: FDA Approved EVAR AAA Graft Systems
    FDA approved comparator of choice

Recruiting Locations

The University of Texas Medical Branch at Galveston
Galveston, Texas 77555
Contact:
Rachel Minesinger
409-747-7333
RAMINESI@UTMB.EDU

More Details

Status
Recruiting
Sponsor
Endologix

Study Contact

Noel DeSisto
864-270-8524
ndesisto@endologix.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.