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

AAA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05409118
• Other study ID #: CP-0022
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: December 2030

Study information

• Verified date: February 2024
• Source: Endologix
• Contact: Noel DeSisto
• Phone: 864-270-8524
• Email: ndesisto[@]endologix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AAA
• AAA - Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Alto Abdominal Stent Graft System
Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
• FDA Approved EVAR AAA Graft Systems
FDA approved comparator of choice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through 5 Years
Primary	Neck Dilation in mm		Through 5 Years
Secondary	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]
Secondary	Count of participants All Cause Mortality		At 30 days, 12 months, and annually up to five years
Secondary	Count of participants AAA-related Mortality		At 30 days, 12 months, and annually up to five years
Secondary	Number of Type Ia endoleaks		At 30 days, 12 months, and annually up to five years
Secondary	Number of Type Ib		At 30 days, 12 months, and annually up to five years
Secondary	Number of Type II		At 30 days, 12 months, and annually up to five years
Secondary	Number of Type III		At 30 days, 12 months, and annually up to five years
Secondary	Number of Type IV		At 30 days, 12 months, and annually up to five years
Secondary	Number of Unknown Enooleaks		At 30 days, 12 months, and annually up to five years
Secondary	Number of Secondary interventions		At 30 days, 12 months, and annually up to five years
Secondary	Count of subjects lacking device integrity	device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak)	At 30 days, 12 months, and annually up to five years
Secondary	Count of aneurysm ruptures		At 30 days, 12 months, and annually up to five years
Secondary	Count of participants with conversion to open surgery		At 30 days, 12 months, and annually up to five years
Secondary	Count of participants with type I and III endoleaks		At 30 days, 12 months, and annually up to five years
Secondary	Count of participants with device migration (>10mm)		12 months, and annually up to five years
Secondary	Count of participants with aneurysm sac enlargement (>5mm)		12 months, and annually up to five years
Secondary	Count of subjects with occlusion		30 days, 12 months, and annually up to five years]
Secondary	Number of Participants with Freedom From device-related interventions		30 days, 12 months, and annually up to five years]