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Endovascular Device

Aortic Endografts for Aortic Aneurysm

N/A

Recruiting

Led By Adam W Beck, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Juxtarenal, suprarenal and thoracoabdominal aortic pathology in hemodynamically stable patients

Intact or contained ruptured aortic or aortoiliac aneurysms involving or in close approximation to the visceral segment of the aorta

Must not have

Unstable angina

Less than 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing three investigational devices to see if they're safe and effective for treating aortic pathologies involving the visceral vessels. This approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.

Who is the study for?

This trial is for stable patients with aortic pathologies like large aneurysms or ulcers near the visceral segment of the aorta. It's not for those under 18, pregnant, with severe allergies to contrast material, infections risking graft infection, poor X-ray visibility due to body shape, life expectancy under one year, or certain heart and artery conditions.

What is being tested?

The study compares three endovascular devices: Cook Custom Aortic Endograft, Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endografts in treating complex aortic issues that standard devices can't fix. The goal is to reduce hospital stays and complications.

What are the potential side effects?

Potential side effects may include local complications at the insertion site such as bleeding or bruising; device-related issues like movement after placement; blood flow problems leading to leg pain or fatigue; and risks associated with any surgical procedure.

Eligibility Criteria

Inclusion Criteria

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

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My aorta condition is stable and located near or above my kidneys.

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I have an aneurysm near my heart or in the artery to my legs.

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My condition involves a growth larger than 5.5 cm, or it has grown more than 0.5 cm in 6 months.

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My tumor has grown more than 0.5 cm in a year.

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My condition causes symptoms or has led to a rupture.

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My condition involves a ruptured or symptomatic issue, regardless of size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have unstable chest pain.

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I am under 18 years old.

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I am unable or unwilling to give my consent for treatment.

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My kidney function is low, but I am not on dialysis.

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I have no major surgeries planned within 30 days after my aneurysm repair.

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I have a permanent blood clotting disorder.

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I have an aortic dissection.

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My aortic disease is caused by an infection.

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I have a blood vessel blockage that cannot be treated.

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My lower large intestine artery cannot be treated with a graft or opening.

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I have a complex issue with the arteries in my abdomen.

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My anatomy allows keeping at least one main pelvic artery open.

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My aorta was injured due to recent trauma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post procedure

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.

Secondary study objectives

Number of subjects that achieve treatment success at 12 months post procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Zenith t-Branch Endovascular GraftExperimental Treatment1 Intervention

Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the sizing of the the Zenith t-Branch Endovascular Graft. The Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents.

Group II: Surgeon-Modified EndograftExperimental Treatment1 Intervention

Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the design of the Surgeon-Modified Endografts. These will be created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.

Group III: Cook Custom Aortic EndograftExperimental Treatment1 Intervention

Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the design of the Cook Custom Aortic Endograft. The Cook Custom Aortic Endograft has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.

0 / 19Eligibility criteria met

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,656 Previous Clinical Trials

2,444,073 Total Patients Enrolled

Cook Group IncorporatedIndustry Sponsor

91 Previous Clinical Trials

15,212 Total Patients Enrolled

Adam W Beck, MD4.58 ReviewsPrincipal Investigator - University of Alabama at Bimingham

University of Alabama at Birmingham

2 Previous Clinical Trials

369 Total Patients Enrolled

5Patient Review

This highly skilled physician saved my life. If you have any vascular issues, you need to see him immediately. I wish he still practiced in my state, but even if he didn't, I would travel to see him. He is simply that good.