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Compares treatment options for Abdominal Aortic Aneurysm
Official title Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
ClinicalTrials.gov ID: NCT05378347
What this study is testing
- What it's testing
- The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Subject and the treating physician agree that the subject will return for all required follow up visits
- Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the...
- Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.
- Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis...
You likely can't join if
- Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial
- Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
- Subject has an aneurysm that is:
- Suprarenal/pararenal/juxtarenal
- Isolated ilio-femoral
- Mycotic
See the full eligibility criteria
- Subject and the treating physician agree that the subject will return for all required follow up visits
- Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee/Institutional Review Board
- Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.
- Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in...
- Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial
- Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
- Subject has an aneurysm that is:
- Suprarenal/pararenal/juxtarenal
- Isolated ilio-femoral
- Mycotic
- Inflammatory
- Pseudoaneurysm
- Concomitant or prior dissection involving the abdominal aorta or iliac arteries
- Ruptured
- Symptomatic AAA
- Subject has significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in...
- Subject requires emergent aneurysm treatment, for example, trauma or rupture
- Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome
- Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease
- Planned use of aorto-uni-iliac (AUI) main body device
- Any planned additional device (apart from the main body, limb stent graft and extensions per assigned treatment per randomization) during index or staged procedure, e.g., endostaple or anchor, Iliac branch...
- Planned coverage of the internal iliac artery/arteries
- Subject has an estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73m2 or subject is on dialysis
- Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion
- Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion
- Subject is of childbearing potential in whom pregnancy cannot be excluded
- Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
- Subject belongs to a vulnerable population per investigator's judgment
- Subject has an active COVID-19 infection or relevant history of COVID- 19
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Skokie, Illinois, United States
- Wichita, Kansas, United States
- Lexington, Kentucky, United States
- Portland, Maine, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Springfield, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
+ 47 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; Newport Beach, California, United States; Orange, California, United States; Sacramento, California, United States; San Francisco, California, United States; Denver, Colorado, United States and 61 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.