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Comparing two stent graft systems for treating abdominal aortic aneurysms

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

Not applicable Interventional Medtronic Cardiovascular · NCT05378347

This study is testing which of two different stent graft systems works better for treating abdominal aortic aneurysms in patients.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment600 (estimated)
Ages20 Years and up
SexAll
SponsorMedtronic Cardiovascular Industry-sponsored
Locations68 sites (Loma Linda, California and 67 other locations)
Trial IDNCT05378347 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to generate clinical evidence comparing the performance outcomes of the Medtronic Endurant II/IIs Stent Graft System and the Gore Excluder/Excluder Conformable AAA Endoprosthesis in patients with abdominal aortic aneurysms (AAA). It is a post-market, prospective, interventional, global, multi-center, randomized, dual-arm trial involving approximately 550 to 900 subjects. Participants will be randomized to receive one of the two stent graft systems, with follow-up imaging collected at discharge, 30 days, and annually for up to five years to assess sac regression outcomes. The trial will evaluate whether one device is superior or non-inferior to the other in terms of effectiveness.

Who should consider this trial

Good fit: Ideal candidates are patients with an abdominal aortic aneurysm measuring 5.0 cm or larger in females and 5.5 cm or larger in males.

Not a fit: Patients with an estimated life expectancy of three years or less or those participating in other investigational studies may not benefit from this trial.

Why it matters

Potential benefit: If successful, this trial could provide insights into which stent graft system offers better outcomes for patients with abdominal aortic aneurysms.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating stent graft systems for abdominal aortic aneurysms, indicating that this trial builds on existing knowledge.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Loma Linda, California and 67 other locations

+18 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Abdominal Aortic AneurysmAbdominal Aortic Aneurysm >= 5.5 Centimeters in MaleAbdominal Aortic Aneurysm >= 5.0 Centimeters in FemaleEVAR, AAA
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.