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Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

NCT05378347 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-04-08

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

Medtronic Endurant II or Endurant IIs Stent Graft System

EVAR treatment with Medtronic Endurant II/IIs Stent Graft System

DEVICE

Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

EVAR treatment with Excluder / Excluder Conformable Stent Graft System

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Marc Schermerhorn, MD · Beth Israel Deaconess Medical Center, United States

  • Hence Verhagen, MD · Erasmus University Medical Center, Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2027-05-31
Completion
2031-05-31
FDA Device
Yes

Countries

  • United States
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Netherlands
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378347 on ClinicalTrials.gov