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JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

NCT05064540 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-06-08

No results posted yet for this study

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

Interventions

DEVICE

Alto Abdominal Stent Graft System

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

DEVICE

FDA Approved EVAR AAA Graft Systems

FDA approved comparator of choice

Sponsors & Collaborators

  • Endologix

    lead INDUSTRY

Principal Investigators

  • Sean Lyden, MD · The Cleveland Clinic

  • Christopher Kwolek, MD · Newton-Wellesley Hospital

  • Hence Verhagen, MD, PhD · Erasmus University Study Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2031-03-31
Completion
2031-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064540 on ClinicalTrials.gov