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ACTIVE NOT RECRUITING
NCT03743142

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

Sponsor: Marc van Sambeek

View on ClinicalTrials.gov

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

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.

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