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Stent Graft System

Stent Graft Systems for Abdominal Aortic Aneurysm (ADVANCE Trial)

N/A

Recruiting

Led By Marc Schermerhorn, MD

Research Sponsored by Medtronic Cardiovascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man)

Be older than 18 years old

Must not have

Subject requires emergent aneurysm treatment, for example, trauma or rupture

Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different types of stents to see which is better at treating abdominal aortic aneurysms. Subjects will be given one of the two types of stents and then monitored over time.

Who is the study for?

This trial is for adults with abdominal aortic aneurysms large enough to require intervention, who can commit to follow-up visits. They must be suitable for both Medtronic Endurant and Gore Excluder stent graft systems. Those with connective tissue diseases, life expectancy under 3 years, severe kidney issues, or certain psychiatric conditions cannot join.

What is being tested?

The ADVANCE Trial compares the performance of two stent graft systems—Medtronic Endurant and Gore Excluder—in treating abdominal aortic aneurysms. Participants are randomly assigned one of the treatments and monitored through imaging to assess outcomes.

What are the potential side effects?

Potential side effects may include local complications at the implant site such as infection or bleeding, allergic reactions to materials or medications used during the procedure, blood vessel damage, and general risks associated with endovascular surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My aneurysm is at least 5 cm wide if I am a woman, or 5.5 cm if I am a man.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need immediate treatment for a ruptured aneurysm.

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I am allergic to blood thinners, anti-clotting drugs, or contrast dyes and cannot be pre-treated for it.

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I currently have COVID-19 or have had it in the past.

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I could be pregnant.

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My kidney function is low or I am on dialysis.

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I have a specific type of aneurysm in my abdomen or pelvis.

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I have significant blood clot or calcium buildup in my artery where a device might be placed.

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I had surgery or a procedure for a bulge or blockage in my main belly artery or its branches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Sac Regression

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Medtronic Endurant II/IIsExperimental Treatment1 Intervention

Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.

Group II: Gore Excluder / Excluder ConformableExperimental Treatment1 Intervention

Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.

0 / 9Eligibility criteria met