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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
Must not have
Known active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I currently have an active infection.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Freedom from Aneurysm-Related Complications (ARC)
Secondary study objectives
Count of subjects lacking device integrity
Number of Major Adverse Events (MAEs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

EndologixLead Sponsor
22 Previous Clinical Trials
3,560 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
~251 spots leftby Dec 2028
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