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Endovascular Device

Stent Graft Systems for Abdominal Aortic Aneurysm (JAGUAR Trial)

N/A

Recruiting

Led By Sean Lyden, MD

Research Sponsored by Endologix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult age 21 and older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years

Awards & highlights

JAGUAR Trial Summary

This trial will compare two types of devices used in a common surgery to fix an aortic aneurysm.

Who is the study for?

The JAGUAR Trial is for adults over 21 with an unruptured infrarenal abdominal aortic aneurysm (AAA) who are expected to live at least two more years. Participants must be able to follow the study's procedures and have signed consent forms. Those with allergies to device materials, pregnant women, or individuals currently in another trial cannot join.Check my eligibility

What is being tested?

This study compares two treatments for AAA: the Alto Abdominal Stent Graft System versus FDA-approved EVAR graft systems. Patients will be randomly assigned to one of these options and monitored from procedure time up until five years post-treatment.See study design

What are the potential side effects?

Potential side effects may include complications related to stent placement such as blood vessel damage, infection, allergic reactions to device materials, and issues related to general anesthesia used during the procedure.

JAGUAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 21 years old or older.

JAGUAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neck Dilation in mm

Number of Participants with Freedom from Aneurysm-Related Complications (ARC)

Secondary outcome measures

Count of participants AAA-related Mortality

Count of participants All Cause Mortality

Count of participants with aneurysm sac enlargement (>5mm)

+15 more

JAGUAR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Alto Abdominal Stent Graft SystemExperimental Treatment1 Intervention

Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.

Group II: ComparatorsActive Control1 Intervention

Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

EndologixLead Sponsor

22 Previous Clinical Trials

3,522 Total Patients Enrolled

Sean Lyden, MDPrincipal InvestigatorThe Cleveland Clinic

8 Previous Clinical Trials

2,453 Total Patients Enrolled

Christopher Kwolek, MDPrincipal InvestigatorNewton-Wellesley Hospital

4 Previous Clinical Trials

1,503 Total Patients Enrolled

Media Library

Alto Abdominal Stent Graft System (Endovascular Device) Clinical Trial Eligibility Overview. Trial Name: NCT05064540 — N/A

Abdominal Aortic Aneurysm Research Study Groups: Alto Abdominal Stent Graft System, Comparators

Abdominal Aortic Aneurysm Clinical Trial 2023: Alto Abdominal Stent Graft System Highlights & Side Effects. Trial Name: NCT05064540 — N/A

Alto Abdominal Stent Graft System (Endovascular Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05064540 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this trial still ongoing?

"The evidence on clinicaltrials.gov suggests that this research project, which was initially advertised on September 20th 2021, is still recruiting participants. The most recent update to the study's information came through October 12th 2022."

Answered by AI

How many subjects are being recruited for participation in this trial?

"To successfully complete the trial, 450 qualified patients need to partake in it. Those interested can attend either Houston Methodist Research Institute located in Texas or University of Arizona based out of Tucson."

Answered by AI

Are there multiple sites in the U.S. conducting this research experiment?

"Presently, 22 medical centres are working to find suitable candidates for this trial. These include the Houston Methodist Research Institute in Houston, University of Arizona in Tucson, as well as Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health) located on Staten Island and many other sites throughout the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

2021. "JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05064540.

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