Abdominal Aortic AneurysmAbdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
Investigational drug(s) / intervention(s)
Medtronic Endurant II or Endurant IIs Stent Graft SystemGore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
Medtronic Endurant II or Endurant IIs Stent Graft System: EVAR treatment with Medtronic Endurant II/IIs Stent Graft System
Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis: EVAR treatment with Excluder / Excluder Conformable Stent Graft System
Study summary
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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Sac Regression — 12 months Proportion of patients with sac regression at 1 year, defined in accordance with SVS guidelines as the reduction in maximum diameter by \>= 5 mm when compared to the first CT imaging study obtained within 90 days after index procedure.
Trial sites (68)
Facility
City
Region
Status
Loma Linda University Medical Center
Loma Linda
California
Recruiting
Hoag Hospital
Newport Beach
California
Recruiting
University of California Irvine Medical Center
Orange
California
Recruiting
University of California Davis Medical Center
Sacramento
California
Withdrawn
University of California San Francisco UCSF Medical Center
San Francisco
California
Recruiting
Denver Health Medical Center
Denver
Colorado
Recruiting
Yale Center for Clinical Investigation
New Haven
Connecticut
Recruiting
Medstar Washington Hospital Center
Washington D.C.
District of Columbia
Recruiting
Mayo Clinic Jacksonville
Jacksonville
Florida
Recruiting
Sarasota Memorial Hospital
Sarasota
Florida
Recruiting
Northside Hospital Forsyth
Atlanta
Georgia
Recruiting
Northshore University Health System
Skokie
Illinois
Recruiting
Ascension Via Christi Saint Francis
Wichita
Kansas
Recruiting
University of Kentucky
Lexington
Kentucky
Recruiting
Maine Medical Center
Portland
Maine
Recruiting
VA Maryland Health Care System
Baltimore
Maryland
Recruiting
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Recruiting
Baystate Medical Center
Springfield
Massachusetts
Recruiting
Minneapolis Heart Institute Foundation
Minneapolis
Minnesota
Recruiting
Mayo Clinic Rochester
Rochester
Minnesota
Recruiting
Albany Medical College
Albany
New York
Withdrawn
Northwell Health Lenox Hill Hospital
New York
New York
Recruiting
Westchester Medical Center
Valhalla
New York
Recruiting
Novant Health Forsyth Medical Center
Winston-Salem
North Carolina
Recruiting
University Hospitals, Cleveland Medical Center
Cleveland
Ohio
Recruiting
Hospital of the University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
Recruiting
Prisma Health
Greenville
South Carolina
Withdrawn
Cardiovascular Surgery Clinic
Memphis
Tennessee
Withdrawn
University of Texas Health Science Center at Houston
Houston
Texas
Recruiting
The Heart Hospital Baylor Plano
Plano
Texas
Recruiting
University of Virginia Health System
Charlottesville
Virginia
Recruiting
Helsinki University Hospital
Helsinki
Finland
Recruiting
Kuopio University Hospital
Kuopio
Finland
Recruiting
Assistance Publique - Hopitaux de Marseille Hopital de la Timone
Marseille
Marseille Cedex
Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
France
Recruiting
Hospices Civils de Lyon-CHU Lyon
Lyon
France
Withdrawn
Hopital de Hautepierre - CHU de Strasbourg
Strasbourg
France
Recruiting
University Hospital Augsburg
Augsburg
Germany
Recruiting
University Hospital Cologne
Cologne
Germany
Recruiting
+ 28 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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