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Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms

NCT03743142 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2025-03-05

No results posted yet for this study

Summary

EVAR continues to evolve as a treatment option for AAA. New devices which are specifically designed to perform adequately across the spectrum of potential anatomic presentations for infrarenal EVAR are needed. The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the EXCeL Registry.

This study will assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (CEXC Device) in patients who meet the IFU anatomic criteria (≥15mm proximal neck length and ≤90˚ proximal neck angulation; and ≥10mm proximal neck length and ≤60˚ proximal neck angulation) and in patients with challenging anatomic presentation that may present outside the IFU anatomic criteria. Successful outcomes from this study will provide evidence to support the CEXC Device as an option for expanding EVAR to a broader patient population with more challenging anatomic presentations.

Conditions

  • Abdominal Aortic Aneurysm (AAA)

Interventions

PROCEDURE

endovascular repair of the AAA

The Investigator will ensure that investigational devices are used only in subjects properly enrolled in the clinical study in accordance with the protocol. Subjects will undergo endovascular repair of their AAA. Procedural details may vary between sites, but will follow standard hospital protocol for EVAR and patient care management.

Sponsors & Collaborators

  • Marc van Sambeek

    lead OTHER

Principal Investigators

  • M.R.H.M. van Sambeek, Prof. dr. · Catharina Ziekenhuis Eindhoven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2025-09-30
Completion
2026-01-31

Countries

  • France
  • Italy
  • Netherlands
  • Spain
  • 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 NCT03743142 on ClinicalTrials.gov