Health TrialsbyHealthPanel

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

ConditionsAAAAAA - Abdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorEndologix

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alto Abdominal Stent Graft System

    Device

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

  • FDA Approved EVAR AAA Graft Systems

    Device

    FDA approved comparator of choice

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Alto Abdominal Stent Graft SystemExperimental treatment 1 intervention
Group B: ComparatorsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through 5 years
2

Neck Dilation in mm

Time frame
Through 5 years

Secondary outcomes

1

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
2

Count of participants All Cause Mortality

Time frame
At 30 days, 12 months, and annually up to five years
3

Count of participants AAA-related Mortality

Time frame
At 30 days, 12 months, and annually up to five years
4

Number of Type Ia endoleaks

Time frame
At 30 days, 12 months, and annually up to five years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Endologix

Lead sponsor

Source ClinicalTrials.gov
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