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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

No Placebo-Only Group

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.

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.

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:

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I am under 18 years old.

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I cannot or will not give my consent to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Number of Subjects Who Achieve Treatment Success

Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire

Awards & Highlights

No Placebo-Only Group

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

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

0 / 3Eligibility criteria met