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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months and annually to 5 years
Awards & highlights
No Placebo-Only Group

ADVANCE Trial 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.

ADVANCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My aneurysm is at least 5 cm wide if I am a woman, or 5.5 cm if I am a man.

ADVANCE Trial 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

ADVANCE 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
35,768 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals may participate in this trial?

"Affirmative. Clinicaltrials.gov indicates that the medical trial, initially posted on December 6th 2022, is currently recruiting and searching for 550 patients from 5 assorted facilities."

Answered by AI

To what extent is this trial being implemented in clinical settings?

"Currently, enrolment for this trial is available at five clinical sites: Winston-Salem, Greenville, Plano and two additional locations. Participants should choose the closest centre to them in order to reduce travel expenses as much as possible."

Answered by AI

Is the trial currently seeking participants?

"Yes, the data on clinicaltrials.gov verifies that this trial is still open for recruitment. Initially uploaded to the website on December 6th 2022 and most recently updated November 21st 2022, it is aiming to enrol 550 patients from 5 sites."

Answered by AI
~285 spots leftby May 2025