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Endovascular Graft

Endovascular Graft + Bridging Stent for Aortic Aneurysm

N/A
Recruiting
Led By Gustavo Oderich, MD
Research Sponsored by Cook Research Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 50 mm
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
Must not have
Inability or refusal to give informed consent by the patient or legally authorized representative
Age < 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess a new medical device to treat aortic aneurysms involving one or more of the major arteries.

Who is the study for?
This trial is for adults with large or rapidly growing aortic aneurysms near the major arteries from the chest to the abdomen. Candidates must not be pregnant, planning pregnancy within 5 years, or involved in other studies. They should expect to live more than 2 years and agree to follow-up visits.
What is being tested?
The study tests the Zenith® Fenestrated+ Endovascular Graft combined with BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System on patients with complex aortic aneurysms, evaluating its safety and effectiveness in treating these conditions.
What are the potential side effects?
While specific side effects are not listed here, endovascular graft procedures may include risks such as blood vessel damage, infection, bleeding complications, stent migration or failure leading to potential surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My aortic aneurysm is 50 mm or larger.
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My aortic aneurysm has grown 5 mm or more in 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot or will not give my consent to participate.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite measure of device technical success and procedural safety
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Aortic abdominal aneurysmExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Cook Research IncorporatedLead Sponsor
30 Previous Clinical Trials
253,765 Total Patients Enrolled
Gustavo Oderich, MDPrincipal InvestigatorMemorial Hermann Texas Medical Center
1 Previous Clinical Trials
200 Total Patients Enrolled
~60 spots leftby Jun 2026
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