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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years post primary procedure

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years post primary procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years post primary procedure

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

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of major adverse events at 30 days post primary procedure

Secondary outcome measures

Average ICU length of stay in peri-operative period

Average length of ventilation past 48 hours in peri-operative period

Freedom from reintervention at 12 months post primary procedure

+38 more

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,182 Total Patients Enrolled

1 Trials studying Aortic Aneurysm

20 Patients Enrolled for Aortic Aneurysm

Cook Group IncorporatedIndustry Sponsor

91 Previous Clinical Trials

15,212 Total Patients Enrolled

15 Trials studying Aortic Aneurysm

2,894 Patients Enrolled for Aortic Aneurysm

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

2 Trials studying Aortic Aneurysm

369 Patients Enrolled for Aortic Aneurysm

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.

Media Library

Cook Custom Aortic Endograft (Endovascular Device) Clinical Trial Eligibility Overview. Trial Name: NCT02043691 — N/A

Aortic Aneurysm Research Study Groups: Surgeon-Modified Endograft, Zenith t-Branch Endovascular Graft, Cook Custom Aortic Endograft

Aortic Aneurysm Clinical Trial 2023: Cook Custom Aortic Endograft Highlights & Side Effects. Trial Name: NCT02043691 — N/A

Cook Custom Aortic Endograft (Endovascular Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02043691 — N/A

Frequently Asked Questions

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

How many individuals are receiving care as part of this experimental trial?

"Affirmative. According to information on clinicaltrials.gov, this medical study which was originally published on June 1st 2014 is currently in recruitment mode. Subsequently, 200 individuals need to be enrolled at one distinct site."

Answered by AI

Is this clinical experiment actively seeking participants?

"Hosted on clinicaltrials.gov, this research project is looking for participants right now. It was first posted on June 1st 2014 and its details have most recently been updated as of January 10th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies

Adam W Beck 2014. "Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02043691.

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