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Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Sponsor: Medtronic Cardiovascular

NCT ID: NCT05378347

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Medtronic Endurant II or Endurant IIs Stent Graft System (device), Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis (device)
How long the study runs
Study runs about 100 months (dates as stated)
About the drug or intervention
Medtronic Endurant II or Endurant IIs Stent Graft System — device: EVAR treatment with Medtronic Endurant II/IIs Stent Graft System · Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis — device: EVAR treatment with Excluder / Excluder Conformable Stent Graft System
Patient visit burden
Not specified by the sponsor

In plain English

This trial compares two types of stent graft (a tube placed inside a blood vessel to repair a swollen artery in the tummy, called an abdominal aortic aneurysm). One is the Medtronic Endurant II/IIs system and the other is the Gore Excluder device. The sponsor is Medtronic Cardiovascular.

Who can take part

  • You agree to return for all required follow-up visits
  • You (or your representative) sign the informed consent form
  • Your aneurysm is at least 5 cm if you are a woman, or 5.5 cm if you are a man (or as stated in regional addenda)
  • The shape of your aneurysm is suitable for both stent graft types, according to your doctor and the study's central review team

Who may not be able to

  • You are taking part in another study of a drug or device that could affect this trial's results
  • Your life expectancy is 3 years or less
  • Your aneurysm is in certain positions or types: above or near the kidneys, in the groin/pelvic arteries only, infected, inflammatory, a pseudoaneurysm, involves a tear (dissection) of the aorta or pelvic arteries, has ruptured, or is causing symptoms
  • You have significant blood clots or calcium at the places where the device would be implanted
  • You need emergency treatment, for example after injury or rupture
  • You have a connective tissue disease such as Marfan, Ehlers-Danlos or Loeys-Dietz syndrome
  • You have had previous surgery or stent treatment on the abdominal aorta or pelvic (iliac) arteries
  • The plan is to use an aorto-uni-iliac device (a stent graft going to only one leg artery)
  • Extra devices beyond the standard ones are planned (for example anchors, special limb devices, or blocking-off procedures)
  • The plan involves covering the internal iliac artery (arteries in the pelvis)
  • Your kidney function is low (eGFR under 45) or you are on dialysis
  • You have a systemic infection that could raise the risk of graft infection
  • You have a psychiatric or other condition that could interfere with the trial
  • You could be pregnant
  • You are allergic to or cannot take blood-thinning medicines or contrast dye (the liquid used for scans)
  • You belong to a group considered vulnerable, in the researcher's judgment
  • You have an active COVID-19 infection or a relevant history of COVID-19

What taking part involves

  • • The trial compares two stent graft systems used to repair an abdominal aortic aneurysm from inside the blood vessel: the Medtronic Endurant II/IIs Stent Graft System and the Gore Excluder AAA Endoprosthesis
  • • Which system you receive is decided by randomisation (like a coin toss)
  • • Further details of the procedures and tests involved are not stated — ask the trial team

Time commitment: Not stated — ask the trial team. The trial requires you to attend all follow-up visits after the procedure.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
20 Years and over
Who
All
Number of participants
600
Started
2023-01-05
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for abdominal aortic aneurysm
  • • NA - 600 participants
  • • 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

Who can take part?

  • • Ages 20 Years and over
  • • Diagnosed with abdominal aortic aneurysm

Where?

  • • Oxford - Oxford University Hospitals NHS Trust - John Radcliffe Hospital
  • • Edinburgh - Royal Infirmary of Edinburgh

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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. Approximately 600 subjects are planned to be enrolled at up to 100 sites globally. 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.

Abdominal Aortic AneurysmAbdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 20 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ follow up visits

What the study is looking for

  • ✓Subject and the treating physician agree that the subject will return for all required follow up visits
  • ✓Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.

Who cannot take part

  • ✗Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints...
  • ✗Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
  • ✗Subject has an aneurysm that is:
  • ✗Suprarenal/pararenal/juxtarenal
  • ✗Isolated ilio-femoral
See the full 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

Where Is This Study? (2 UK sites)

Oxford University Hospitals NHS Trust - John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Dominic Howard, BM B.Ch MA DPhil (Oxon) FRCSPrincipal Investigator

Royal Infirmary of Edinburgh

Edinburgh EH16 4SA, United Kingdom

Recruiting
Site contact (verified)
Andrew Tambyraja, MDPrincipal Investigator

How to Get in Touch

ADVANCE Trial Clinical Study Team

Sponsor contact

CONTACT

763-514-4000 rs.advancestudy@medtronic.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07