JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Endologix

Status: Enrolling

Conditions: AAA; AAA - Abdominal Aortic Aneurysm

Treatments: Device: Alto Abdominal Stent Graft System; Device: FDA Approved EVAR AAA Graft Systems

Study type: Interventional

Funder types: Industry

Identifiers

NCT05064540

CP-0017

Details and patient eligibility

About

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).

Enrollment: 450 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Alto Abdominal Stent Graft System

Experimental group

Description:

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

Treatment:

Device: Alto Abdominal Stent Graft System

Comparators

Active Comparator group

Description:

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

Treatment:

Device: FDA Approved EVAR AAA Graft Systems