Hellenic Registry of Ovation Alto™ Abdominal Stent Graft System

Study Overview
=================
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.

Official Title
-----------------
Hellenic Registry of Subjects Receiving the Ovation Alto™ Abdominal Stent Graft System

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Ovation Alto™ Abdominal Stent Graft System


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group/Cohort<br>Ovation Alto™ Abdominal Stent Graft System Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria. | Device: Ovation Alto™ Abdominal Stent Graft System<br>* Single occurrence permanent implantation of AAA device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Classification of Endoleaks | Endoleak type Ia and Ib and III | 1 and 12 months | 
| Stent Graft Migration | Any proximal caudal Stent Graft Migration >10mm | 1 and 12 months | 
| Abdominal aortic aneurysm sac enlargement | Any sac enlargement > 5mm | 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 | 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 | 1 and 12 months | 
| 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 | 1 and 12 months | 
| AAA-related mortality | Any aneurysm related mortality | 1 and 12 months | 
| Device-related Adverse Events (AEs) | Device-related Adverse Events: loss of latency, stent fracture, migration, Endoleak type I and III | 1 and 12 months | 
| Major adverse events | Including death, myocardial infarction, stroke, chronic renal disease, stent graft infection, amputation | 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 | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EVAR, Endovascular aneurysm repair, Ovation Alto