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Summary
Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)
Official title: Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
48
Start Date
2016-11
Completion Date
2024-02-27
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.
Locations (10)
Klinikum Augsburg Klinik für Gefäßchirurgie
Augsburg, Germany
St. Marien Hospital Bonn
Bonn, Germany
University Hospital Koeln
Cologne, Germany
University Hospital Heidelberg
Heidelberg, Germany
TUM Munich
Munich, Germany
Rijnstate Hospital
Arnhem, Netherlands
St Elisabeth Ziekenhuis, Dept of Vascular Surgery
Tilburg, Netherlands
Auckland City Hospital
Auckland, New Zealand
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Universitario y Politécnico de La Fe
Valencia, Spain