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Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Recruiting

Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression

Who can join

Ages 20 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Medtronic Cardiovascular · Participants: 600 · Started: Jan 5, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05378347

Locations in the U.S.

CaliforniaLoma Linda University Medical Center, Loma Linda
Hoag Hospital, Newport Beach
University of California Irvine Medical Center, Orange
University of California San Francisco UCSF Medical Center, San Francisco
ColoradoDenver Health Medical Center, Denver
ConnecticutYale Center for Clinical Investigation, New Haven
District of ColumbiaMedstar Washington Hospital Center, Washington D.C.
FloridaMayo Clinic Jacksonville, Jacksonville
Sarasota Memorial Hospital, Sarasota
GeorgiaNorthside Hospital Forsyth, Atlanta
IllinoisNorthshore University Health System, Skokie
KansasAscension Via Christi Saint Francis, Wichita
KentuckyUniversity of Kentucky, Lexington
MaineMaine Medical Center, Portland
MarylandVA Maryland Health Care System, Baltimore
MassachusettsBeth Israel Deaconess Medical Center, Boston
Baystate Medical Center, Springfield
MinnesotaMinneapolis Heart Institute Foundation, Minneapolis
Mayo Clinic Rochester, Rochester
New YorkNorthwell Health Lenox Hill Hospital, New York
Westchester Medical Center, Valhalla
North CarolinaNovant Health Forsyth Medical Center, Winston-Salem
OhioUniversity Hospitals, Cleveland Medical Center, Cleveland
PennsylvaniaHospital of the University of Pennsylvania, Philadelphia
University of Pittsburgh Medical Center, Pittsburgh
TexasUniversity of Texas Health Science Center at Houston, Houston
The Heart Hospital Baylor Plano, Plano
VirginiaUniversity of Virginia Health System, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.