Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
- Conditions
- Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)Abdominal Aortic AneurysmAbdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
- Interventions
- Device: Medtronic Endurant II or Endurant IIs Stent Graft SystemDevice: Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
- Registration Number
- NCT05378347
- Lead Sponsor
- Medtronic Cardiovascular
- Brief 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.
- Detailed Description
This is a post-market, prospective, interventional, global, multi-center, randomized, dual-arm clinical trial. The primary objective of this trial is to evaluate sac regression outcomes of the Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis in standard EVAR subjects. Subjects are randomized on a 1:1 basis to receive EVAR with either a Medtronic Endurant II/IIs Stent Graft Systems or Gore Excluder / Excluder Conformable AAA Endoprosthesis. Data is collected pre- and post-procedure at discharge, at 30 days, and once a year until the 5-year follow-up is completed. An estimate of 550 subjects (minimum 500) are enrolled at up to 100 sites globally, with the potential to extend enrollment up to 900 subjects based on predictive probability analysis to adequately achieve either non-inferiority or superiority for the primary endpoint.
Product Names:
* Medtronic Endurant II/IIs Stent Graft System
* Gore Excluder and/or Gore Excluder Conformable AAA Endoprosthesis Imaging is collected for all follow-up time points and are evaluated by a core lab for the key primary and secondary objectives.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
- Subject and the treating physician agree that the subject will return for all required followup 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)
- 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.
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Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial
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Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
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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
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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.
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Subject requires emergent aneurysm treatment, for example, trauma or rupture
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Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome
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Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease
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Planned use of aorto-uni-iliac (AUI) main body device
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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.
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Planned coverage of the internal iliac artery/arteries
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Subject has an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 or subject is on dialysis
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Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion
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Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion
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Subject is of childbearing potential in whom pregnancy cannot be excluded
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Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
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Subject belongs to a vulnerable population per investigator's judgment
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Subject has an active COVID-19 infection or relevant history of COVID- 19
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medtronic Endurant II/IIs Medtronic Endurant II or Endurant IIs Stent Graft System 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. Gore Excluder / Excluder Conformable Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Secondary intervention incidence rate 30 days, 12 months and annually to 5 years Type II endoleak incidence rate 30 days, 12 months and annually to 5 years Type I endoleak incidence rate 30 days,12 months and annually to 5 years All cause mortality incidence rate 30 days, 12 months and annually to 5 years Aneurysm sac change by volume incidence rate 12 months and annually to 5 years Aneurysm sac change by diameter as a continuous variable 12 months and annually to 5 years
Trial Locations
- Locations (67)
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Hoag Hospital
🇺🇸Newport Beach, California, United States
University of California Irvine Medical Center
🇺🇸Orange, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
University of California San Francisco UCSF Medical Center
🇺🇸San Francisco, California, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Yale Center for Clinical Investigation
🇺🇸New Haven, Connecticut, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Northside Hospital Forsyth
🇺🇸Atlanta, Georgia, United States
Northshore University Health System
🇺🇸Skokie, Illinois, United States
Ascension Via Christi Saint Francis
🇺🇸Wichita, Kansas, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
VA Maryland Health Care System
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Albany Medical College
🇺🇸Albany, New York, United States
Northwell Health Lenox Hill Hospital
🇺🇸New York, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Novant Health Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University Hospitals, Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
Cardiovascular Surgery Clinic
🇺🇸Memphis, Tennessee, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Helsinki University Hospital
🇫🇮Helsinki, Finland
Kuopio University Hospital
🇫🇮Kuopio, Finland
Assistance Publique - Hopitaux de Marseille Hopital de la Timone
🇫🇷Marseille, Marseille Cedex, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Hospices Civils de Lyon-CHU Lyon
🇫🇷Lyon, France
Hopital de Hautepierre - CHU de Strasbourg
🇫🇷Strasbourg, France
University Hospital Augsburg
🇩🇪Augsburg, Germany
University Hospital Cologne
🇩🇪Cologne, Germany
Elisabeth Hospital Essen
🇩🇪Essen, Germany
Universitatsklinikum Frankfurt
🇩🇪Frankfurt, Germany
University Hospital Leipzig
🇩🇪Leipzig, Germany
University Hospital rechts der Isar of the Technical University Munich
🇩🇪Munich, Germany
St. Franziskus Hospital Munster
🇩🇪Münster, Germany
University Hospital of Larisa
🇬🇷Larisa, Greece
Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
AOU Citta della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Asahikawa Medical University Hospital
🇯🇵Asahikawa City, Hokkaido, Japan
Niigata University Medical and Dental Hospital
🇯🇵Chuo Ku, Niigata, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
Rijnstate Hospital
🇳🇱Arnhem, The Netherlands, Netherlands
Amsterdam University Medical Center
🇳🇱Amsterdam, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Hospital Universitario Son Espases
🇪🇸Palma, Mallorca, Spain
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Luzerner Kantonsspital
🇨🇭Luzern, Switzerland
China Medical University Hospital
🇨🇳Taichung, Taiwan
Chi Mei Medical Center
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Oxford University Hospitals NHS Trust - John Radcliffe Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom