Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study

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.

Endoleak is defined by the persistence of blood flow outside the lumen of the endovascular graft but within the aneurysm sac and can be classified as:

• Type I - Ineffective seal at either the proximal or distal sealing zones

• Type IA - Ineffective seal at the proximal sealing zone
• Type IB - Ineffective seal at the distal sealing zone
• Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac
• Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration
• Type IIIA - Junctional leak or component disconnection
• Type IIIB - Midgraft hole
• Type IV - Blood flow through an intact fabric.
• Unknown endoleak - Endoleak present but unable to assess type Endoleak will only be evaluated as an adverse event or serious adverse event if it is present at the 30-day follow-up visit or if a post-index procedure re-intervention occurs.

any change of stent graft migration (movement) greater than 10mm

Change in aneurysm diameter greater than 5mm

A tear in the abdominal aorta that can result in serious internal bleeding.

conversion to open abdominal surgery to repair AAA

Intervention occurring after index procedure and having to do with device or AAA.

death caused by or related to AAA

Device-Related: Event is caused or contributed by any component of the device during delivery, deployment or while the device is in situ post-operatively

Major adverse events (MAE) are defined as any one of the following events:

• Death
• Myocardial Infarction
• Stroke (excludes TIA)
• Renal Failure (excludes renal insufficiency)
• Respiratory Failure (excludes chronic obstructive pulmonary disease (COPD) or pulmonary complications)
• Paralysis (excludes paraparesis)
• Bowel Ischemia
• Procedural Blood Loss (≥1,000 cc)

The integrity of the stent graft is evaluated by the Independent Core Lab via abdominal X-rays at regularly scheduled follow-up visits. Any fractured stents, and any other issues compromising the integrity of the stent graft will be reported.

The integrity of the stent graft is evaluated by the Independent Core Lab via abdominal X-rays at regularly scheduled follow-up visits. Any fractured stents, and any other issues compromising the integrity of the stent graft will be reported.

An adverse event is any new, undesirable medical occurrence or change (worsening) of a pre-existing condition that occurs in a subject, whether or not considered to be associated with the product

Procedure-Related event is caused or contributed by the initial study device implantation (index) procedure, up to 30 days, unless a different etiology can be identified

A serious adverse event (SAE) defined as one that suggests a significant hazard or side effect, regardless of the investigator or Sponsor's opinion on the relationship to the investigational product. This includes, but may not be limited to, any event that:

• Is fatal
• Is life-threatening
• Requires or prolongs (>48 hours) inpatient hospitalization
• Is a persistent or significant disability or incapacity
• Is considered an important medical event