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Stent Graft

Fenestrated Stent Graft for Abdominal Aortic Aneurysm (IDE#1 Trial)

N/A
Recruiting
Led By Gustavo Oderich, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aneurysm with a history of growth ≥ 0.5 cm per year
Be older than 18 years old
Must not have
Less than 18 years of age
Inability or refusal to give informed consent by the patient or a legally authorized representative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.
Awards & highlights

Summary

This trial is testing a new type of stent for aortic aneurysms. They will compare outcomes and quality of life measures for patients who receive this new stent to those who don't.

Who is the study for?
This trial is for adults with complex abdominal aortic aneurysms, specifically juxtarenal, suprarenal, or type IV thoracoabdominal types that are at high risk of rupture. Candidates should have aneurysms ≥5.0 cm or twice the normal size, or those growing ≥0.5 cm per year. Excluded are individuals under 18, pregnant/breastfeeding women, those unwilling to follow up, with less than 2 years life expectancy or other medical/anatomical restrictions.Check my eligibility
What is being tested?
The study tests the effectiveness and quality of life impact of using custom-made Cook Zenith® Fenestrated AAA Endovascular Grafts in repairing complex abdominal aortic aneurysms close to the kidneys and above.See study design
What are the potential side effects?
While not specified here, endovascular graft procedures can generally lead to side effects such as bleeding at the access site, infection, blood vessel damage near the graft and potential issues related to kidney function due to proximity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My aneurysm has grown at least 0.5 cm in a year.

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years. 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 die at 30 days post treatment
Secondary outcome measures
Number of Subjects Who Achieve Treatment Success
Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire

Trial Design

1Treatment groups
Experimental Treatment
Group I: EndovascularExperimental Treatment1 Intervention
The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, 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. Other names: Endovascular stent Stent-graft

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Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,206 Total Patients Enrolled
4 Trials studying Aortic Aneurysm
297 Patients Enrolled for Aortic Aneurysm
Gustavo OderichLead Sponsor
1 Previous Clinical Trials
530 Total Patients Enrolled
1 Trials studying Aortic Aneurysm
530 Patients Enrolled for Aortic Aneurysm
Cook Group IncorporatedIndustry Sponsor
91 Previous Clinical Trials
15,312 Total Patients Enrolled
15 Trials studying Aortic Aneurysm
2,994 Patients Enrolled for Aortic Aneurysm

Media Library

Custom-made Zenith® Fenestrated AAA Endovascular Graft (Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT01937949 — N/A
Aortic Aneurysm Research Study Groups: Endovascular
Aortic Aneurysm Clinical Trial 2023: Custom-made Zenith® Fenestrated AAA Endovascular Graft Highlights & Side Effects. Trial Name: NCT01937949 — N/A
Custom-made Zenith® Fenestrated AAA Endovascular Graft (Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01937949 — N/A
~10 spots leftby Mar 2025
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