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

Primary Purpose

AAA, AAA - Abdominal Aortic Aneurysm

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Alto Abdominal Stent Graft System

FDA Approved EVAR AAA Graft Systems

About this trial

This is an interventional treatment trial for AAA

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alto Abdominal Stent Graft System

Comparators

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Neck Dilation in mm

Secondary Outcome Measures

Number of Major Adverse Events (MAEs)

All-cause mortality, Bowel ischemia, Myocardial infarction, Paraplegia, Renal Failure, Respiratory Failure, Stroke, Index Procedural Blood Loss ≥ 1000mL

Count of participants All Cause Mortality

Count of participants AAA-related Mortality

Number of Type Ia endoleaks

Number of Type Ib

Number of Type II

Number of Type III

Number of Type IV

Number of Unknown Enooleaks

Number of Secondary interventions

Count of subjects lacking device integrity

device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak)

Count of aneurysm ruptures

Count of participants with conversion to open surgery

Count of participants with type I and III endoleaks

Count of participants with device migration (>10mm)

Count of participants with aneurysm sac enlargement (>5mm)

Count of subjects with occlusion

Number of Participants with Freedom From device-related interventions

Full Information

NCT ID

NCT05409118

First Posted

June 3, 2022

Last Updated

February 13, 2023

Sponsor

Endologix

1. Study Identification

Unique Protocol Identification Number

NCT05409118

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

December 2028 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endologix

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

AAA, AAA - Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alto Abdominal Stent Graft System

Arm Type

Experimental

Arm Description

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

Arm Title

Comparators

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Alto Abdominal Stent Graft System

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

FDA Approved EVAR AAA Graft Systems

Other Intervention Name(s)

Medtronic Endurant, Cook Zenith, Gore Excluder

Intervention Description

FDA approved comparator of choice

Primary Outcome Measure Information:

Title

Number of Participants with Freedom from Aneurysm-Related Complications (ARC)

Description

Time Frame

Through 5 Years

Title

Neck Dilation in mm

Time Frame

Through 5 Years

Secondary Outcome Measure Information:

Title

Number of Major Adverse Events (MAEs)

Description

All-cause mortality, Bowel ischemia, Myocardial infarction, Paraplegia, Renal Failure, Respiratory Failure, Stroke, Index Procedural Blood Loss ≥ 1000mL

Time Frame

[Time Frame: At 30 days and 12 months]

Title

Count of participants All Cause Mortality

Time Frame