The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient ≥ 18 years old
✓. Patient has given written informed consent
✓. Patient has a life expectancy \> 1 year
✓. Patient is willing to comply with follow-up evaluations
✓. Patient's AAA meets at least one of the following criteria:
✓. Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm
✓. Patient has a proximal aortic neck length of at least 12mm
✓. Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.
Exclusion criteria
✕. Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results
✕. Patient has a symptomatic AAA
✕. Patient's AAA has a proximal aortic neck angle that is \> 60 degrees between the infrarenal neck and the long axis of the aneurysm
✕. Patient has irregularly-shaped plaque that would inhibit sealing stent apposition
✕. Patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site
✕. Patient has an active, or known history of, bleeding diathesis or hypercoagulable condition
✕. Patient has a contraindication to any materials to which he or she will be exposed during the EVAR procedure (i.e., Fortevo Endograft or Heli-FX EndoAnchor System materials, contrast agents)
✕. Patient has a genetic connective tissue disorder (e.g., Marfan's or Ehlers-Danloe Syndromes)