JAGUAR Trial (Outside United States; OUS): ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Endologix

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

AAA AAA - Abdominal Aortic Aneurysm

Interventions

Alto Abdominal Stent Graft SystemDEVICE

Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.

FDA Approved EVAR AAA Graft SystemsDEVICE

FDA approved comparator of choice

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants with Freedom from Aneurysm-Related Complications (ARC)

Composite endpoint consisting of aneurysm-related death, aneurysm rupture, conversion to open surgery, type I and III endoleaks, device migration (\>10mm), aneurysm sac enlargement (\>5mm), occlusion, and freedom from device-related interventions

Time frame: Through 5 Years

Neck Dilation in mm

Time frame: Through 5 Years

Secondary Outcomes

Number of Major Adverse Events (MAEs)

All-cause mortality, Bowel ischemia, Myocardial infarction, Paraplegia, Renal Failure, Respiratory Failure, Stroke, Index Procedural Blood Loss ≥ 1000mL

Time frame: [Time Frame: At 30 days and 12 months]

Count of participants All Cause Mortality