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JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization (JAGUAR)

Primary Purpose

AAA, AAA - Abdominal Aortic Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alto Abdominal Stent Graft System
FDA Approved EVAR AAA Graft Systems
Sponsored by
Endologix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AAA focused on measuring randomized

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

  • Huntsville HospitalRecruiting
  • University of ArizonaRecruiting
  • Washington Regional Medical CenterRecruiting
  • Central Arkansas Veterans Healthcare SystemRecruiting
  • The Regents of the University of California, San DiegoRecruiting
  • Veterans Affairs San Diego Healthcare SystemRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Jacksonville Center for Clinical ResearchRecruiting
  • Radiology and Imaging SpecialistsRecruiting
  • Baptist Hospital of Miami, Miami Cardiac and Vascular InstituteRecruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • University of LouisvilleRecruiting
  • Henry Ford HospitalRecruiting
  • University of MissouriRecruiting
  • Newark Beth Israel Medical CenterRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)Recruiting
  • The Cleveland Clinical FoundationRecruiting
  • The Ohio State UniversityRecruiting
  • Oregon Health Sciences UniversityRecruiting
  • U.S. Department of Veterans Affairs, VA Portland Health Care SystemRecruiting
  • Lehigh Valley Health NetworkRecruiting
  • University of PennsylvaniaRecruiting
  • Allegheny Health NetworkRecruiting
  • Wellmont Cardiology ServicesRecruiting
  • The University of Texas Medical Branch at GalvestonRecruiting
  • Houston Methodist Research InstituteRecruiting
  • Sentara HospitalsRecruiting

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

First Posted
September 18, 2021
Last Updated
September 5, 2023
Sponsor
Endologix
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1. Study Identification

Unique Protocol Identification Number
NCT05064540
Brief Title
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Acronym
JAGUAR
Official Title
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
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
Keywords
randomized

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
Intervention Description
FDA approved comparator of choice
Primary Outcome Measure Information:
Title
Number of Participants with Freedom from Aneurysm-Related Complications (ARC)
Description
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
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
At 30 days and 12 months
Title
Count of participants All Cause Mortality
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Count of participants AAA-related Mortality
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Number of Type Ia endoleaks
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Number of Type Ib
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Number of Type II
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Number of Type III
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Number of Type IV
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Number of Unknown Enooleaks
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Number of Secondary interventions
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Count of subjects lacking device integrity
Description
device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak)
Time Frame
At 30 days, 12 months, and annually up to five years
Title
count of aneurysm ruptures
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Count of participants with conversion to open surgery
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Count of participants with type I and III endoleaks
Time Frame
At 30 days, 12 months, and annually up to five years
Title
Count of participants with device migration (>10mm)
Time Frame
12 months, and annually up to five years
Title
Count of participants with aneurysm sac enlargement (>5mm)
Time Frame
12 months, and annually up to five years
Title
Count of subjects with occlusion
Time Frame
30 days, 12 months, and annually up to five years
Title
Number of Participants with Freedom From device-related interventions
Time Frame
30 days, 12 months, and annually up to five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noel DeSisto
Phone
864-270-8524
Email
ndesisto@endologix.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Huxford
Email
Chuxford@endologix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Lyden, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Kwolek, MD
Organizational Affiliation
Newton-Wellesley Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hence Verhagen, MD, PhD
Organizational Affiliation
Erasmus University Study Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsville Hospital
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Heffington
Phone
256-265-7480
Email
kheffvvc@yahoo.com
First Name & Middle Initial & Last Name & Degree
Casey Green
Email
caseyvvc@yahoo.com
First Name & Middle Initial & Last Name & Degree
Fred Stucky, MD
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85716
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayman Sami
Email
aymansami@arizona.edu
First Name & Middle Initial & Last Name & Degree
Wei Zhou, MD
Facility Name
Washington Regional Medical Center
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Callie McQueen
Phone
479-463-7858
Email
cmcqueen@wregional.com
First Name & Middle Initial & Last Name & Degree
Russell Wood
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Brock
Phone
501-257-6906
Email
sandra.brock@va.gov
First Name & Middle Initial & Last Name & Degree
Lisa Adams
Phone
501-257-6926
Email
lisa.adams@va.gov
First Name & Middle Initial & Last Name & Degree
Mohammed Moursi
Facility Name
The Regents of the University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Groh
Phone
951-595-2347
Email
kagroh@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Mahmoud Malas, MD
Facility Name
Veterans Affairs San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalicia Romero
Email
annalicia.romero@va.gov
First Name & Middle Initial & Last Name & Degree
Andrew Barleben, MD
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassaye Sesaba
Phone
202-877-7452
Email
Kassaye.T.Sesaba@medstar.net
First Name & Middle Initial & Last Name & Degree
Fatima Javariah, MD
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Joseph
Phone
904-732-2217
Email
ljoseph@encoredocs.com
First Name & Middle Initial & Last Name & Degree
Erin Moore, MD
Facility Name
Radiology and Imaging Specialists
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eve Johnson
Phone
863-688-2334
Ext
135
Email
ejohnson@risimaging.com
First Name & Middle Initial & Last Name & Degree
Tushar Barot, MD
Facility Name
Baptist Hospital of Miami, Miami Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Fernandez
Phone
786-596-5392
Email
davidfer@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Mikaela Bearham
Phone
786-596-4079
Email
MikaelaB@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Constantino Pena, MD
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Pena-Quevedo, RN, MSN
Phone
319-353-8736
First Name & Middle Initial & Last Name & Degree
Mel Sharafuddin, MD
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1959
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Haysley
Phone
502-852-2801
Email
leslie.haysley@louisville.edu
First Name & Middle Initial & Last Name & Degree
Amit Dwivedi, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Lanthier
Phone
313-916-6199
Email
hlanthi1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Timothy Nypaver, MD
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Randolph
Phone
573-882-4387
Email
Randolphjl@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Todd Vogel, MD
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Cook
Email
Debra.cook@rwjbh.org
First Name & Middle Initial & Last Name & Degree
Bruce Brener, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leigh Neuburger
Phone
212-241-8250
Email
Leigh.Neuburger@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Sarah McCracken
Phone
(212) 241-8250
Email
sarah.mccracken@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Sung Yup Kim, MD
Facility Name
Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health)
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Pantea
Phone
718-226-6438
Email
apantea@northwell.edu
First Name & Middle Initial & Last Name & Degree
Shannen Belotte
Phone
718-226-8559
Email
sbelotte@northwell.edu
First Name & Middle Initial & Last Name & Degree
Kuldeep Singh, MD
Facility Name
The Cleveland Clinical Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Czich, RN
Phone
216-315-1568
Email
CZICHC@ccf.org
First Name & Middle Initial & Last Name & Degree
Jarrad Rowse, Dr.
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subhashish Das
Phone
614-366-6596
Email
Subhashish.Das@osumc.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Murphy
Phone
614 685-9864
Email
Elizabeth.Murphy@osumc.edu
First Name & Middle Initial & Last Name & Degree
Mounir Haurani, MD
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Steger
Email
stegerd@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Samantha Underwood
Email
underwos@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Cherie Abraham, MD
Facility Name
U.S. Department of Veterans Affairs, VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Avalos
Email
kathy.avalos@va.gov
First Name & Middle Initial & Last Name & Degree
Rachel Nelson
Phone
503-220-8262
Ext
58388
Email
rachel.nelson1@va.gov
First Name & Middle Initial & Last Name & Degree
Matthew Koopmann, MD
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Mankos
Phone
610-402-1635
Email
deborah.mankos@lvhn.org
First Name & Middle Initial & Last Name & Degree
Benjamin Jackson, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courteney Ly
Phone
856-381-9687
Email
courteney.ly@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Venkat Kalapatapu, MD
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Bernardini
Email
sheila.bernardini@ahn.org
First Name & Middle Initial & Last Name & Degree
Satish Muluk, MD
Facility Name
Wellmont Cardiology Services
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Lester
First Name & Middle Initial & Last Name & Degree
Christopher Metzger, MD
Facility Name
The University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Minesinger
Phone
409-747-7333
Email
RAMINESI@UTMB.EDU
First Name & Middle Initial & Last Name & Degree
Michael Silva, MD
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kikelomo Akindoju
Phone
832-794-4962
Email
kakindoju@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Sanjana Taassum
Phone
346-238-8240
Email
stabassum@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Alan Lumsden, MD
Facility Name
Sentara Hospitals
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melinda Bullivant, MSN, RN
Phone
757-388-4024
Email
mmbulliv@sentara.com
First Name & Middle Initial & Last Name & Degree
Jean M. Panneton, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with others.

Learn more about this trial

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

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