JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

AAA Clinical Trial

— JAGUAR  

Official title:

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05064540
• Other study ID #: CP-0017
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: December 2028

Study information

• Verified date: March 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: Recruiting
• Enrollment: 450
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• 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
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	The Cleveland Clinical Foundation	Cleveland	Ohio
United States	University of Missouri	Columbia	Missouri
United States	The Ohio State University	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	The University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Houston Methodist Research Institute	Houston	Texas
United States	Huntsville Hospital	Huntsville	Alabama
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Wellmont Cardiology Services	Kingsport	Tennessee
United States	The Regents of the University of California, San Diego	La Jolla	California
United States	Radiology and Imaging Specialists	Lakeland	Florida
United States	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas
United States	University of Louisville	Louisville	Kentucky
United States	Baptist Hospital of Miami, Miami Cardiac and Vascular Institute	Miami	Florida
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Hospitals	Norfolk	Virginia
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	U.S. Department of Veterans Affairs, VA Portland Health Care System	Portland	Oregon
United States	Veterans Affairs San Diego Healthcare System	San Diego	California
United States	Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)	Staten Island	New York
United States	University of Arizona	Tucson	Arizona
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Country where clinical trial is conducted

United States, 

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	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