This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.
Study Type
OBSERVATIONAL
Enrollment
60
Single occurrence permanent implantation of AAA device
University Hospital of Larisssa
Larissa, Greece
RECRUITINGTreatment success
Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration \> 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement \>5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months.
Time frame: 12 months
Number and Classification of Endoleaks
Endoleak type Ia and Ib and III
Time frame: 1 and 12 months
Stent Graft Migration
Any proximal caudal Stent Graft Migration \>10mm
Time frame: 1 and 12 months
Abdominal aortic aneurysm sac enlargement
Any sac enlargement \> 5mm
Time frame: 1 and 12 months
Aortic neck alteration
Any neck diameter increase at supra-renal part of the aorta (at 0mm, 10mm and 20mm above the highest renal artery), and infra-renal part of the aorta (at 0mm, 7mm, and 15mm below the lowest renal artery). Measurements of the aortic neck angulation will also be included
Time frame: 1 and 12 months
Freedom from abdominal aortic aneurysm rupture
Recording of any abdominal aortic aneurysm rupture that takes place during the follow up after the procedure in order to assess freedom from this adverse event
Time frame: 1 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of Secondary Interventions
Any secondary intervention stent-graft related including: proximal extension with a balloon expandable covered stent; stent graft extension distally to common iliac arteries; use of onyx for Endoleak Ia; bare metal stent in external iliac arteries
Time frame: 1 and 12 months
AAA-related mortality
Any aneurysm related mortality
Time frame: 1 and 12 months
Device-related Adverse Events (AEs)
Device-related Adverse Events: loss of latency, stent fracture, migration, Endoleak type I and III
Time frame: 1 and 12 months
Major adverse events
Including death, myocardial infarction, stroke, chronic renal disease, stent graft infection, amputation
Time frame: 1 and 12 months
Adherence to instruction for use
Recording of patients in terms of adherence to instructions for use according to the device manual
Time frame: 12 months