The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects. All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.
Study Type
OBSERVATIONAL
Enrollment
108
The Fortevo Endograft, Main Body and Iliac Lumen Delivery System are indicated for the endovascular treatments of patients with infrarenal abdominal aortic aneurysms or aortic-iliac aneurysms having suitable morphology for endovascular repair.
Sherbrooke University Hospital Centre
Sherbrooke, Quebec, Canada
German Heart Center
Berlin, Germany
Cardiovascular Center Frankfurt
Frankfurt, Germany
St. Bonifatious Hospital
Lingen, Germany
Technical Success
The first primary endpoint is primary technical success. It consists of the following items: * Successful arterial access * Successful deployment of the Fortevo Endograft with secure proximal and distal fixation * Absence of type I or III endoleaks * Patent Fortevo Endograft without significant twist, kinking, or obstruction
Time frame: Within 24 hours of the Index procedure
Major Adverse Events (MAE)
The second primary endpoint is associated with the safety profile of the device, and is defined as the percent of patients experiencing one or more of major adverse events (MAE) within one month of implantation. MAE are defined as any one of the following events: * Death * Myocardial Infarction * Stroke (excludes TIA) * Renal failure (excludes renal insufficiency) * Respiratory Failure (excludes COPD or pulmonary complications) * Paralysis (excludes paraparesis)
Time frame: Within 1-Month of Implantation
Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components
Clinical Success is defined as Successful Deployment of the Fortevo Endograft at the intended location and the absence of: * Death as a result of aneurysm-related treatment * Type I or III endoleak * Fortevo Endograft infection * Fortevo Endograft thrombosis * Fortevo Endograft dilatation by 20% or more in diameter * Fortevo Endograft migration by 10mm or more at the proximal neck at 6-M and 12-M * Loss of Fortevo Endograft or Heli-FX EndoAnchor System integrity * Aneurysm expansion by 5mm (or more) in maximal diameter at 6-M and 12-M * Aneurysm rupture * Conversion to open repair
Time frame: 1-Month, 6-Months and 12-Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hellenic Airforce Hospital
Athens, Greece
University of Siena
Siena, Italy
St Antonious Hospital
Nieuwegein, Netherlands
Thorax Institute Hospital Clinic
Barcelona, Spain
University of Navarra
Pamplona, Spain