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

NCT ID: NCT05409118

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2030-12-31

Brief Summary

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

AAA; AAA - Abdominal Aortic Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alto Abdominal Stent Graft System

Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.

Group Type: EXPERIMENTAL

Alto Abdominal Stent Graft System

Intervention Type: DEVICE

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

Comparators

Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.

Group Type: ACTIVE_COMPARATOR

FDA Approved EVAR AAA Graft Systems

Intervention Type: DEVICE

FDA approved comparator of choice

Interventions

Alto Abdominal Stent Graft System

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

Intervention Type: DEVICE

FDA Approved EVAR AAA Graft Systems

FDA approved comparator of choice

Intervention Type: DEVICE

Other Intervention Names

Medtronic Endurant, Cook Zenith, Gore Excluder

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endologix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Lyden, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Christopher Kwolek, MD

Role: PRINCIPAL_INVESTIGATOR

Newton-Wellesley Hospital

Hence Verhagen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus University Study Center

Other Identifiers

CP-0022

Identifier Type: -

Identifier Source: org_study_id