Clinical trial NCT05409118: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: AAA
AAA - Abdominal Aortic Aneurysm
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2022-06-08
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: [Time Frame: 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:
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: