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Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms
Sponsor: Marc van Sambeek
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
156
Start Date
2018-09-11
Completion Date
2026-01-31
Last Updated
2025-03-05
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (8)
APHP Hopital Européen
Paris, France
San Martino Hospital
Genova, Italy
Rijnstate Hospital
Arnhem, Netherlands
Catharina Hospital
Eindhoven, Netherlands
ETZ
Tilburg, Netherlands
San Carlos Hospital
Madrid, Spain
Complexo Hospitalario de Orense
Ourense, Spain
North Bristol NHS Trust
Bristol, United Kingdom