Abdominal Aortic Aneurysm
Conditions
Keywords
EVAR, Endovascular aneurysm repair, Ovation Alto
Brief summary
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.
Interventions
DEVICEOvation Alto™ Abdominal Stent Graft System
Single occurrence permanent implantation of AAA device
Sponsors
University of Patras
University Hospital of Crete
University Hospital, Alexandroupolis
Larissa University Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is \> 18 years of age * Both IFU and non-adherence to IFU * Subject intends to electively receive the Ovation Alto™ Abdominal Stent Graft System * Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan
Exclusion criteria
* Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results. * Life expectancy less than 1 year * Pregnancy * Subjects with poor renal function as indicated by a serum creatinine \> 2.5mg/dl.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Graft Migration | 1 and 12 months | Any proximal caudal Stent Graft Migration \>10mm |
| Abdominal aortic aneurysm sac enlargement | 1 and 12 months | Any sac enlargement \> 5mm |
| Aortic neck alteration | 1 and 12 months | 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 |
| Freedom from abdominal aortic aneurysm rupture | 1 and 12 months | 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 |
| Number and Classification of Endoleaks | 1 and 12 months | Endoleak type Ia and Ib and III |
| AAA-related mortality | 1 and 12 months | Any aneurysm related mortality |
| Device-related Adverse Events (AEs) | 1 and 12 months | Device-related Adverse Events: loss of latency, stent fracture, migration, Endoleak type I and III |
| Major adverse events | 1 and 12 months | Including death, myocardial infarction, stroke, chronic renal disease, stent graft infection, amputation |
| Adherence to instruction for use | 12 months | Recording of patients in terms of adherence to instructions for use according to the device manual |
| Number of Secondary Interventions | 1 and 12 months | 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 |
Countries
Greece
Contacts
Primary ContactKonstantinos Spanos, PhD
Backup ContactAthanasios Giannoukas, Prof
Outcome results
None listed