Comparing two stent graft systems for treating abdominal aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to generate clinical evidence comparing the performance outcomes of the Medtronic Endurant II/IIs Stent Graft System and the Gore Excluder/Excluder Conformable AAA Endoprosthesis in patients with abdominal aortic aneurysms (AAA). It is a post-market, prospective, interventional, global, multi-center, randomized, dual-arm trial involving approximately 550 to 900 subjects. Participants will be randomized to receive one of the two stent graft systems, with follow-up imaging collected at discharge, 30 days, and annually for up to five years to assess sac regression outcomes. The trial will evaluate whether one device is superior or non-inferior to the other in terms of effectiveness.

Why it matters

Who can join: the full rules

Inclusion 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 accordance with the overlapping commercially available IFUs per applicable region.

Exclusion Criteria:

* 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:

  1. Suprarenal/pararenal/juxtarenal
  2. Isolated ilio-femoral
  3. Mycotic
  4. Inflammatory
  5. Pseudoaneurysm
  6. Concomitant or prior dissection involving the abdominal aorta or iliac arteries
  7. Ruptured
  8. 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 thickness and / or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck.
* 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 endoprosthesis, embolization, etc.
* 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

Where it's running

• Loma Linda University Medical Center
  Loma Linda, California, United States Recruiting
• Hoag Hospital
  Newport Beach, California, United States Recruiting
• University of California Irvine Medical Center
  Orange, California, United States Recruiting
• University of California San Francisco UCSF Medical Center
  San Francisco, California, United States Recruiting
• Denver Health Medical Center
  Denver, Colorado, United States Recruiting
• Yale Center for Clinical Investigation
  New Haven, Connecticut, United States Recruiting

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Marc Schermerhorn, MD — Beth Israel Deaconess Medical Center, United States
• Study coordinator: ADVANCE Trial Clinical Study Team
• Email: rs.advancestudy@medtronic.com
• Phone: 763-514-4000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Cygnum aneurysm sac lining used with EVAR for abdominal aortic aneurysm

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.