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Procedure

Modified Stent Grafts for Aortic Aneurysm

N/A
Waitlist Available
Led By Bernardo Mendes, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient will be deemed anatomically high risk if has prior intraabdominal operation(s), prior abdominal wall reconstructions, prior radiation therapy targeting abdomen and/or pelvis, or history of intraabdominal sepsis
Patient will be deemed physiologically high risk if older than 75 years of age, has chronic obstructive pulmonary disease, congestive heart failure, previous myocardial infarction, coronary stent, bypass, chronic renal insufficiency with baseline eGFR < 40 ml/min, or ASA score > 3
Must not have
Anatomic exclusion criteria include inadequate femoral or iliac access, inability to perform iliac conduit, absence of non-aneurysmal aortic segment, visceral vessel anatomy not compatible with stent graft, and unsuitable distal iliac artery fixation site
Medical exclusion criteria include known sensitivities or allergies to specific materials, history of anaphylactic reaction to contrast material, uncorrectable coagulopathy, mycotic aneurysm, active systemic infection, history of specific connective tissue disorders, or body habitus that would inhibit X-ray visualization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test how safe and effective it is to use modified stent grafts with holes or branches to treat specific types of aortic aneurysms that involve the area near the kidneys

Who is the study for?
This trial is for patients with specific types of aortic aneurysms, including juxtarenal, pararenal, and thoracoabdominal. Participants should require endovascular treatment but the exact eligibility criteria are not provided in the information given.
What is being tested?
The study is testing the safety and effectiveness of modified stent grafts (Cook Alpha TX2 Stent Graft, Cook Zenith TX2, Cook Zenith Fenestrated) in treating complex aortic aneurysms that may involve iliac arteries.
What are the potential side effects?
While specific side effects are not listed here, common risks associated with stent graft procedures include bleeding, infection at the incision site, blood vessel damage, and potential complications related to heart and kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had previous surgeries or treatments in my abdomen or pelvis, or a history of severe abdominal infections.
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I am over 75 or have serious health issues like heart or lung disease, kidney problems, or a high ASA score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood vessels are not suitable for certain types of stent graft surgery.
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I don't have allergies to specific materials, severe reactions to contrast dye, bleeding disorders, fungal aneurysms, ongoing infections, certain connective tissue diseases, or a body shape that limits X-ray use.
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I am over 18, can follow the study plan, can consent, am not pregnant or breastfeeding, and expect to live more than 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months 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 patients with major adverse events
Treatment success
Secondary study objectives
Change in Quality of Life

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: Subjects with urgent or emergent aneurysmsExperimental Treatment1 Intervention
Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft
Group II: Subjects with thoracoabdominal aortic aneurysmsExperimental Treatment1 Intervention
Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft
Group III: Subjects with short neck infrarenal, juxtarenal, suprarenal and extent IV TAAExperimental Treatment1 Intervention
Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,444 Total Patients Enrolled
5 Trials studying Aortic Aneurysm
497 Patients Enrolled for Aortic Aneurysm
Bernardo Mendes, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
204 Total Patients Enrolled
1 Trials studying Aortic Aneurysm
150 Patients Enrolled for Aortic Aneurysm
~33 spots leftby Jul 2026
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