Your session is about to expire
← Back to Search
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
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months and annually to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months and annually to 5 years
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 moreADVANCE 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
35,782 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need immediate treatment for a ruptured aneurysm.My treatment includes covering the internal iliac artery.You are not planning to have any additional devices inserted during the main procedure, such as staples, stents, or embolization devices.You are planning to use a specific type of medical device called an aorto-uni-iliac (AUI) main body device.I am allergic to blood thinners, anti-clotting drugs, or contrast dyes and cannot be pre-treated for it.Your aortic aneurysm (AAA) fits the requirements for both the Medtronic Endurant II/IIs Stent Graft System and the Gore Excluder/Excluder Conformable AAA Endoprosthesis, as determined by your doctor and a specialized lab.I currently have COVID-19 or have had it in the past.My aneurysm is at least 5 cm wide if I am a woman, or 5.5 cm if I am a man.I have a connective tissue disorder like Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome.I could be pregnant.My kidney function is low or I am on dialysis.I have a specific type of aneurysm in my abdomen or pelvis.I have significant blood clot or calcium buildup in my artery where a device might be placed.I had surgery or a procedure for a bulge or blockage in my main belly artery or its branches.You have a widespread infection and might be at higher risk for a certain type of infection, as determined by the doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Gore Excluder / Excluder Conformable
- Group 2: Medtronic Endurant II/IIs
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger