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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 and annually to 5 years
Awards & highlights

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~12 months and annually to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and annually to 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
Sac Regression
Secondary outcome measures
All cause mortality incidence rate
Aneurysm sac change by diameter as a continuous variable
Aneurysm sac change by volume incidence rate
+3 more

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.

Find a Location

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,821 Total Patients Enrolled
Marc Schermerhorn, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center, United States
3 Previous Clinical Trials
636 Total Patients Enrolled
Hence Verhagen, MDPrincipal InvestigatorErasmus University Medical Center, Netherlands

Media Library

Endurant Stent Graft System (Stent Graft System) Clinical Trial Eligibility Overview. Trial Name: NCT05378347 — N/A
Abdominal Aortic Aneurysm Research Study Groups: Gore Excluder / Excluder Conformable, Medtronic Endurant II/IIs
Abdominal Aortic Aneurysm Clinical Trial 2023: Endurant Stent Graft System Highlights & Side Effects. Trial Name: NCT05378347 — N/A
Endurant Stent Graft System (Stent Graft System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05378347 — N/A
~183 spots leftby May 2025
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