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

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 Overview

• Status: Withdrawn
• Conditions: AAA; AAA - Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Alto Abdominal Stent Graft System; Device: FDA Approved EVAR AAA Graft Systems

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Other Names: Medtronic Endurant, Cook Zenith, Gore Excluder

What is the study measuring?

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]

Collaborators and Investigators

• Sponsor: Endologix
• Investigators: Principal Investigator: Sean Lyden, MD, The Cleveland Clinic; Principal Investigator: Christopher Kwolek, MD, Newton-Wellesley Hospital; Principal Investigator: Hence Verhagen, MD, PhD, Erasmus University Study Center

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CP-0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with others

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes