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Clinical Trials in the UK / NCT05378347
Recruiting Not applicable

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

NCT05378347 · tracked via the Priya Life Science UK tracker
Sponsor
Medtronic Cardiovascular
Phase
Not applicable
Started
2023-01-05
Last updated
2026-07-06

Condition(s) studied

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)

Trial sites (68)

FacilityCityRegionStatus
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.

More Medtronic Cardiovascular trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT05378347 on ClinicalTrials.gov ↗ ← All trials in the UK