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Stent Graft

Stent-Graft for Aortic Aneurysm (IDE#2 Trial)

N/A
Recruiting
Led By Gustavo S. Oderich, MD FACS
Research Sponsored by Gustavo S. Oderich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In the setting of more distal disease: The repair may be coupled with a thoracoabdominal branched device, infrarenal device, and/or internal iliac branch device
Iliac anatomy must allow for the delivery of the arch branch device which is loaded within a 20F-24F sheath. Thus the iliac requirements are no different than the standard thoracic protocol. Conduits to the iliac vessels or aorta may be used if deemed necessary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post treatment
Awards & highlights

IDE#2 Trial Summary

This trial is testing a new type of stent-graft to see if it is safe and effective in repairing aortic aneurysm.

Who is the study for?
Adults with specific aortic aneurysms or dissections who are not pregnant, breastfeeding, or have a life expectancy under 2 years. They must be willing to follow the trial schedule and give consent. Exclusions include recent surgeries unrelated to the condition, participation in certain other trials, allergies to device materials, uncorrectable coagulopathy, active infections, certain connective tissue disorders.Check my eligibility
What is being tested?
The Zenith t-Branch and customized stent-graft systems are being tested for safety and effectiveness in repairing complex aortic aneurysms. These devices use fenestrations/branches designed for each patient's unique anatomy.See study design
What are the potential side effects?
Potential side effects may include reactions to device materials (stainless steel, nitinol), complications from implantation like bleeding or infection, allergic reactions to contrast material used during surgery if pre-medication is insufficient.

IDE#2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My treatment may include a specific device for my lower torso condition.
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My body can accommodate a specific device for my heart surgery.
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I have an aneurysm in both my chest and upper stomach area.
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My aorta fits the required size and position for the procedure.
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My aneurysm has grown at least 0.5 cm in a year.
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My aorta or graft is 20-42mm wide with a neck length of at least 20mm.
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I am eligible for a customized vascular graft procedure.
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My aortic dissection can be accessed and treated with a stent through my groin.
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My aorta is enlarged, measuring 5.5 cm or more, or twice its normal size.
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My doctor thinks my aneurysm is at high risk of bursting.
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I have a large aneurysm in my chest or abdomen and in the arteries to my legs.

IDE#2 Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects who experience a Major Adverse Event at 30 days post treatment
Number of subjects who have died at 30 days post treatment
Secondary outcome measures
Mean Quality of Life Measure at Various Time Points
Percentage of subjects who achieve treatment success

IDE#2 Trial Design

2Treatment groups
Experimental Treatment
Group I: Thoracoabdominal Aortic Aneurysm ArmExperimental Treatment1 Intervention
The TAAA study arm will include patients treated by endovascular aortic repair of thoracoabdominal aortic aneurysms (Extent I to IV) using either an off-the-shelf Zenith t-Branch or patient-specific stent-graft with a combination of fenestrations and/or branches. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
Group II: Aortic Arch Aneurysm ArmExperimental Treatment1 Intervention
Aortic Arch study arm will include patients with aortic arch aneurysms treated by Patient-specific stent-grafts with one to three inner branches or a scallop. The study will include patients with thoracoabdominal and/or aortic arch aneurysms due to degenerative aneurysms or chronic aortic dissections. The stent-graft design for this study will be individually selected based on anatomy at the discretion of the principal investigator, including an off-the-shelf stent-graft (t-Branch stent-graft) or patient-specific stent-graft with a combination of fenestrations and/or branches.

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Who is running the clinical trial?

Gustavo S. OderichLead Sponsor
Gustavo OderichLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
William Cook AustraliaIndustry Sponsor
4 Previous Clinical Trials
674 Total Patients Enrolled

Media Library

Zenith t-Branch and customized physician-specified stent-graft (Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT02089607 — N/A
Abdominal Aortic Aneurysm Research Study Groups: Thoracoabdominal Aortic Aneurysm Arm, Aortic Arch Aneurysm Arm
Abdominal Aortic Aneurysm Clinical Trial 2023: Zenith t-Branch and customized physician-specified stent-graft Highlights & Side Effects. Trial Name: NCT02089607 — N/A
Zenith t-Branch and customized physician-specified stent-graft (Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02089607 — 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 participants are being admitted to this experiment?

"Indeed, the data on clinicaltrials.gov shows that this research endeavour is actively seeking patients to join in. The trial was initially announced on March 1st 2014 and has subsequently been updated as recently as October 31st 2022. 530 individuals are being sought at a single medical site for participation in the study."

Answered by AI

Are there any open slots available for those interested in participating in this experiment?

"Clinicaltrials.gov verifies that this medical research is still open to enrolment, having been initially posted on March 1st 2014 and recently updated on October 31st 2022."

Answered by AI
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~44 spots leftby Mar 2025