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)
Study Type
OBSERVATIONAL
Enrollment
300
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.
Klinikum Augsburg Klinik für Gefäßchirurgie
Augsburg, Germany
St. Marien Hospital Bonn
Bonn, Germany
University Hospital Koeln
Cologne, Germany
University Hospital Heidelberg
Number of subjects with Immediate Procedural Technical Success
Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.
Time frame: 30 Days
Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs)
Safety endpoint is measured with the number of subjects who are reported freedome of major adverse events (MAEs) including (1) all-cause death, (2) bowel ischemia, (3) myocardial infarction, (4) paraplegia, (5) renal failure, (6) respiratory failure, (7) stroke, and (8) Blood Loss \> 1000mL at 30 Days post index procedure.
Time frame: 30 Days
Number of subjects with Aneurysm rupture
The number of patients experiencing a rupture of the aneurysm will be summarized at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
Time frame: 5 years
Number of subjects with Conversion to open surgical repair
The number of patients undergoing surgical conversion to open repair will be provided at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
Time frame: 5 years
Number of subjects with Endoleak of any type
The number of patients with any endoleak, and patients with each endoleak type at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5) will be summarized.
Time frame: 5 years
Number of subjects with Clinically significant migration
The number of patients with clinically significant migration will be summarized descriptively.
Time frame: 5 years
Number of subjects with Aneurysm enlargement
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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
The number of patients with Aneurysm enlargement will be summarized descriptively. Sac enlargement is defined in the protocol as increase in late follow-up compared to the initial post-op measurement.
Time frame: 5 years
Number of incidence with Secondary endovascular procedures
The overall secondary procedure incidence and the individual component incidence will be provided.
Time frame: 5 years