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Recruiting NCT05064540

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

No phase Interventional AAA AAA - Abdominal Aortic Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alto Abdominal Stent Graft System, FDA Approved EVAR AAA Graft Systems.
Who it may be relevant to
Registry conditions: AAA, AAA - Abdominal Aortic Aneurysm. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

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

Primary outcome measures

  • Number of Participants with Freedom from Aneurysm-Related Complications (ARC) [Time frame: Through 5 years]
  • Neck Dilation in mm [Time frame: Through 5 years]
Secondary outcome measures (12)
  • Number of Major Adverse Events (MAEs) [Time frame: At 30 days and 12 months]
  • Count of participants All Cause Mortality [Time frame: At 30 days, 12 months, and annually up to five years]
  • Count of participants AAA-related Mortality [Time frame: At 30 days, 12 months, and annually up to five years]
  • Number of Type Ia endoleaks [Time frame: At 30 days, 12 months, and annually up to five years]
  • Number of Type Ib [Time frame: At 30 days, 12 months, and annually up to five years]
  • Number of Type II [Time frame: At 30 days, 12 months, and annually up to five years]
  • Number of Type III [Time frame: At 30 days, 12 months, and annually up to five years]
  • Number of Type IV [Time frame: At 30 days, 12 months, and annually up to five years]
  • Number of Unknown Enooleaks [Time frame: At 30 days, 12 months, and annually up to five years]
  • Number of Secondary interventions [Time frame: At 30 days, 12 months, and annually up to five years]
  • Count of subjects lacking device integrity [Time frame: At 30 days, 12 months, and annually up to five years]
  • count of aneurysm ruptures [Time frame: At 30 days, 12 months, and annually up to five years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 29 centers
  • Huntsville Hospital — Huntsville
  • University of Arizona — Tucson
  • Washington Regional Medical Center — Fayetteville
  • Central Arkansas Veterans Healthcare System — Little Rock
  • The Regents of the University of California, San Diego — La Jolla
  • Veterans Affairs San Diego Healthcare System — San Diego
  • MedStar Washington Hospital Center — Washington D.C.
  • Jacksonville Center for Clinical Research — Jacksonville
  • … and 21 more centers

Identifiers

NCT: NCT05064540 · CP-0017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗