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

Study Overview
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Brief Summary
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A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).

Detailed Description
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A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA). The primary objective is to evaluate treatment success at 12 months with the Ovation Alto Abdominal Stent Graft system. The study will have up to 16 sites, and up to 75 patients based on attrition rates. The follow-up intervals will be at 1, 6, and 12 months following initial implant procedure.

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

Conditions
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Aortic Aneurysm, Abdominal

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria include: Patient has adequate iliac/femoral access compatible with the required delivery systems. Patient has non-aneurysmal proximal aortic neck. Patient has non-aneurysmal distal iliac landing zone. Exclusion Criteria include: Patient has dissecting aneurysm. Patient has acutely ruptured aneurysm. Patient has need for emergent surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ovation Alto Abdominal Stent Graft System<br>Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System. | Device: Ovation Alto Abdominal Stent Graft System<br>* Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With 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 |
| --- | --- | --- |
| Event Rates for Endoleaks | 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. | 1 month, 6 months, 12 months | 
| Number of Participants With Stent Graft Migration > 10mm | any change of stent graft migration (movement) greater than 10mm | 6 months, 12 months | 
| Number of Participants With AAA Enlargement > 5mm | Change in aneurysm diameter greater than 5mm | 6 months, 12 months | 
| Number of Participants With AAA Rupture | A tear in the abdominal aorta that can result in serious internal bleeding. | 30 day, Day 31-365 | 
| Number of Participants With Conversion to Open Repair | conversion to open abdominal surgery to repair AAA | 30 day, Day 31-365 | 
| Number of Secondary Interventions | Intervention occurring after index procedure and having to do with device or AAA. | 30 days, Day 31-365 | 
| Number of Participants With AAA-related Mortality | death caused by or related to AAA | 1 month, Day 31-365 | 
| Device-related Adverse Events (AEs) | 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 | 30 days, Day 31-365 | 
| Major Adverse Events | 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) | 1 year | 
| Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression) | 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. | 1 month, 6 months, 12 months | 
| Number of Participants With Stent Fracture | 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. | 1 month, 6 months, 12 months | 
| Adverse Events (Serious and Non-serious) | 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 | 30 days, Day 31-365 | 
| Procedure-related Adverse Event | 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 | 30 days, Day 31-365 | 
| Serious Adverse Event | 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 | 30 Days, Day31-365) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aneurysm, abdominal, aortic