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

Study Overview
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Brief Summary
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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).

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

Conditions
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AAA, AAA - Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Alto Abdominal Stent Graft System
* Device: FDA Approved EVAR AAA Graft Systems


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alto Abdominal Stent Graft System<br>Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm. | Device: Alto Abdominal Stent Graft System<br>* Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.<br>|
| Active Comparator: Comparators<br>Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm. | Device: FDA Approved EVAR AAA Graft Systems<br>* FDA approved comparator of choice<br>* Other names: Medtronic Endurant, Cook Zenith, Gore Excluder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through 5 Years | 
| Neck Dilation in mm |  | Through 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: At 30 days and 12 months] | 
| Count of participants All Cause Mortality |  | At 30 days, 12 months, and annually up to five years | 
| Count of participants AAA-related Mortality |  | At 30 days, 12 months, and annually up to five years | 
| Number of Type Ia endoleaks |  | At 30 days, 12 months, and annually up to five years | 
| Number of Type Ib |  | At 30 days, 12 months, and annually up to five years | 
| Number of Type II |  | At 30 days, 12 months, and annually up to five years | 
| Number of Type III |  | At 30 days, 12 months, and annually up to five years | 
| Number of Type IV |  | At 30 days, 12 months, and annually up to five years | 
| Number of Unknown Enooleaks |  | At 30 days, 12 months, and annually up to five years | 
| Number of Secondary interventions |  | At 30 days, 12 months, and annually up to five years | 
| Count of subjects lacking device integrity | device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak) | At 30 days, 12 months, and annually up to five years | 
| Count of aneurysm ruptures |  | At 30 days, 12 months, and annually up to five years | 
| Count of participants with conversion to open surgery |  | At 30 days, 12 months, and annually up to five years | 
| Count of participants with type I and III endoleaks |  | At 30 days, 12 months, and annually up to five years | 
| Count of participants with device migration (>10mm) |  | 12 months, and annually up to five years | 
| Count of participants with aneurysm sac enlargement (>5mm) |  | 12 months, and annually up to five years | 
| Count of subjects with occlusion |  | 30 days, 12 months, and annually up to five years] | 
| Number of Participants with Freedom From device-related interventions |  | 30 days, 12 months, and annually up to five years] |