Clinical trial NCT05064540: JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Official title: JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AAA
AAA - Abdominal Aortic Aneurysm
Keywords: randomized
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Number of Participants with Freedom from Aneurysm-Related Complications (ARC)
timeFrame: Through 5 years
measure: Neck Dilation in mm
timeFrame: Through 5 years
Secondary outcomes:
measure: Number of Major Adverse Events (MAEs)
timeFrame: At 30 days and 12 months
measure: Count of participants All Cause Mortality
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Count of participants AAA-related Mortality
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Number of Type Ia endoleaks
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Number of Type Ib
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Number of Type II
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Number of Type III
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Number of Type IV
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Number of Unknown Enooleaks
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Number of Secondary interventions
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Count of subjects lacking device integrity
timeFrame: At 30 days, 12 months, and annually up to five years
measure: count of aneurysm ruptures
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Count of participants with conversion to open surgery
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Count of participants with type I and III endoleaks
timeFrame: At 30 days, 12 months, and annually up to five years
measure: Count of participants with device migration (>10mm)
timeFrame: 12 months, and annually up to five years
measure: Count of participants with aneurysm sac enlargement (>5mm)
timeFrame: 12 months, and annually up to five years
measure: Count of subjects with occlusion
timeFrame: 30 days, 12 months, and annually up to five years
measure: Number of Participants with Freedom From device-related interventions
timeFrame: 30 days, 12 months, and annually up to five years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Fayetteville
country: United States
facility: Washington Regional Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: La Jolla
country: United States
facility: The Regents of the University of California, San Diego
state: California
city: San Diego
country: United States
facility: Veterans Affairs San Diego Healthcare System
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lakeland
country: United States
facility: Radiology and Imaging Specialists
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Staten Island
country: United States
facility: Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinical Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Portland
country: United States
facility: U.S. Department of Veterans Affairs, VA Portland Health Care System
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont Cardiology Services
state: Tennessee
city: Galveston
country: United States
facility: The University of Texas Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Norfolk
country: United States
facility: Sentara Hospitals
state: Virginia
Study officials:
affiliation: The Cleveland Clinic
name: Sean Lyden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newton-Wellesley Hospital
name: Christopher Kwolek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus University Study Center
name: Hence Verhagen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: