Aortic Aneurysm, Abdominal
Conditions
Keywords
abdominal, aortic, aneurysm
Brief summary
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
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.
Interventions
DEVICEOvation Alto Abdominal Stent Graft System
Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System
Sponsors
Endologix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
include: 1. Patient has adequate iliac/femoral access compatible with the required delivery systems. 2. Patient has non-aneurysmal proximal aortic neck. 3. Patient has non-aneurysmal distal iliac landing zone.
Exclusion criteria
include: 1. Patient has dissecting aneurysm. 2. Patient has acutely ruptured aneurysm. 3. Patient has need for emergent surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With 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 |
|---|---|---|
| Number of Participants With Stent Graft Migration > 10mm | 6 months, 12 months | any change of stent graft migration (movement) greater than 10mm |
| Number of Participants With AAA Enlargement > 5mm | 6 months, 12 months | Change in aneurysm diameter greater than 5mm |
| Number of Participants With AAA Rupture | 30 day, Day 31-365 | A tear in the abdominal aorta that can result in serious internal bleeding. |
| Number of Participants With Conversion to Open Repair | 30 day, Day 31-365 | conversion to open abdominal surgery to repair AAA |
| Number of Secondary Interventions | 30 days, Day 31-365 | Intervention occurring after index procedure and having to do with device or AAA. |
| Number of Participants With AAA-related Mortality | 1 month, Day 31-365 | death caused by or related to AAA |
| Event Rates for Endoleaks | 1 month, 6 months, 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. |
| Major Adverse Events | 1 year | 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) |
| Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression) | 1 month, 6 months, 12 months | 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. |
| Number of Participants With Stent Fracture | 1 month, 6 months, 12 months | 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. |
| Adverse Events (Serious and Non-serious) | 30 days, Day 31-365 | 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 Adverse Event | 30 days, Day 31-365 | 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 |
| Serious Adverse Event | 30 Days, Day31-365) | 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 |
| Device-related Adverse Events (AEs) | 30 days, Day 31-365 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ovation Alto Abdominal Stent Graft System Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.
Ovation Alto Abdominal Stent Graft System: Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 68 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 73 years STANDARD_DEVIATION 7 |
| Aortic diameter inferior renal Average | 22.5 mm STANDARD_DEVIATION 2.5 |
| Aortic diameter inferior renal Maximum | 23.2 mm STANDARD_DEVIATION 2.6 |
| Aortic diameter inferior renal Minimum | 21.8 mm STANDARD_DEVIATION 2.5 |
| Aortic diameter inferior renal +10mm Average | 22.6 mm STANDARD_DEVIATION 2.5 |
| Aortic diameter inferior renal +10mm Maximum | 23.4 mm STANDARD_DEVIATION 2.8 |
| Aortic diameter inferior renal +10mm Minimum | 21.8 mm STANDARD_DEVIATION 2.5 |
| Aortic diameter Inferior Renal -35mm Average | 25.9 mm STANDARD_DEVIATION 2.3 |
| Aortic diameter Inferior Renal -35mm Maximum | 26.6 mm STANDARD_DEVIATION 2.4 |
| Aortic diameter Inferior Renal -35mm Minimum | 25.0 mm STANDARD_DEVIATION 2.3 |
| Aortic diameter inferior renal +7mm Average | 22.4 mm STANDARD_DEVIATION 2.4 |
| Aortic diameter inferior renal +7mm Maximum | 23.0 mm STANDARD_DEVIATION 2.7 |
| Aortic diameter inferior renal +7mm Minimum | 21.8 mm STANDARD_DEVIATION 2.3 |
| ASA Class Class 1/2 | 5 Participants |
| ASA Class Class 3/4 | 70 Participants |
| Calculated BMI | 30 kg/m^2 STANDARD_DEVIATION 5 |
| Cardiovascular History AICD | 0 Participants |
| Cardiovascular History Angina pectoris or chest discomfort | 5 Participants |
| Cardiovascular History Anticoagulant medication | 7 Participants |
| Cardiovascular History Arrhythmia | 17 Participants |
| Cardiovascular History Cardiomyopathy | 3 Participants |
| Cardiovascular History Congestive Heart Failure | 6 Participants |
| Cardiovascular History Coronary Artery Disease | 35 Participants |
| Cardiovascular History Hyperlipidemia | 57 Participants |
| Cardiovascular History Hypertension | 62 Participants |
| Cardiovascular History Hypotension | 0 Participants |
| Cardiovascular History ICD | 1 Participants |
| Cardiovascular History Myocardial Infarction | 11 Participants |
| Cardiovascular History Other | 10 Participants |
| Cardiovascular History Pacemaker | 3 Participants |
| Cardiovascular History Prior CABG | 5 Participants |
| Cardiovascular History Prior PTCA | 3 Participants |
| Cardiovascular History Prior Valve Repair | 0 Participants |
| Cardiovascular History Prior Valve Replacement | 2 Participants |
| Cardiovascular History Stents | 7 Participants |
| Cardiovascular History Valvular Heart Disease | 11 Participants |
| Change from diameter at inferior renal artery to inferior renal artery diameter at +7mm | 0.0 % STANDARD_DEVIATION 7.2 |
| Distance from the most distal renal artery to most superior left internal iliac artery | 182.5 mm STANDARD_DEVIATION 24.7 |
| Distance from the most distal renal artery to most superior right internal iliac artery (mm) 75 181. | 181.2 mm STANDARD_DEVIATION 21 |
| Endocrine History Diabetes Type I | 0 Participants |
| Endocrine History Diabetes Type II | 22 Participants |
| Endocrine History Diabetic incompressible vessels | 0 Participants |
| Endocrine History Hyperthyroidism or Hypothyroidism | 8 Participants |
| Endocrine History Immunodeficiency | 2 Participants |
| Endocrine History Other | 5 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Bowel fistulas | 0 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Bowel ischemia | 0 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Bowel obstruction | 1 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Chronic Renal Failure | 0 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Chronic urinary tract infections | 1 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Gastrointestinal bleeding | 2 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Impotence including erectile dysfunction | 8 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Incontinence bladder problems | 3 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Other | 42 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Paralytic or adynamic ileus | 0 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Receiving any form of dialysis | 0 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Renal Insufficiency | 5 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Renal Microemboli | 0 Participants |
| Height | 179 cm STANDARD_DEVIATION 9 |
| Hematological History Anemia | 5 Participants |
| Hematological History Coagulopathy disorder | 0 Participants |
| Hematological History Hemorrhage | 0 Participants |
| Hematological History Other | 5 Participants |
| Hematological History Platelet Disorder | 0 Participants |
| Inferior Renal to Aortic Bifurcation | 110.9 mm STANDARD_DEVIATION 13.1 |
| Juxtarenal angle | 23.1 degrees STANDARD_DEVIATION 18.7 |
| Left Ankle Brachial Index | 1 ratio STANDARD_DEVIATION 0 |
| Left distal iliac diameter Average | 15.8 mm STANDARD_DEVIATION 3.1 |
| Left distal iliac diameter Maximum | 16.4 mm STANDARD_DEVIATION 3.3 |
| Left distal iliac diameter Minimum | 15.1 mm STANDARD_DEVIATION 3 |
| Left distal iliac landing zone | 49.1 mm STANDARD_DEVIATION 18.7 |
| Left external iliac diameter Average | 8.2 mm STANDARD_DEVIATION 1.7 |
| Left external iliac diameter Maximum | 8.7 mm STANDARD_DEVIATION 1.6 |
| Left external iliac diameter Minimum | 7.6 mm STANDARD_DEVIATION 1.9 |
| Maximum Sac Diameter ≥40, <50 mm | 23 Participants |
| Maximum Sac Diameter <40 mm | 4 Participants |
| Maximum Sac Diameter ≥ 50, <60 mm | 40 Participants |
| Maximum Sac Diameter ≥ 60 mm | 8 Participants |
| Miscellaneous Medical History Allergy, Intolerance to PTFE, polymers, FEP, nitinol | 0 Participants |
| Miscellaneous Medical History Cancer | 14 Participants |
| Miscellaneous Medical History Connective Tissue Disorder | 0 Participants |
| Miscellaneous Medical History Hypersensitivity to anticoagulation, contrast | 0 Participants |
| Miscellaneous Medical History Liver Disease | 5 Participants |
| Miscellaneous Medical History Other significant medical, surgical history | 26 Participants |
| Native Bifurcation Maximum | 26.2 mm STANDARD_DEVIATION 6.7 |
| Native Bifurcation Minimum | 20.1 mm STANDARD_DEVIATION 5.1 |
| Neck Length | 27.9 mm STANDARD_DEVIATION 13.7 |
| Neurological History Chronic Back Pain | 18 Participants |
| Neurological History Chronic Headaches, Migraines | 3 Participants |
| Neurological History Other | 20 Participants |
| Neurological History Paraplegia | 0 Participants |
| Neurological History Parasthesia | 1 Participants |
| Neurological History Reversible Ischemic Neurologic Disease | 0 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Abdominal Aortic Aneurysm | 75 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Aneurysms | 75 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Atherosclerosis | 8 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Carotid artery disease | 6 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Cerebral Aneurysm | 0 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Chronic Venous Insufficiency | 2 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Claudication | 4 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Deep Venous Thrombosis | 3 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Family History of Aneurysms | 9 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Other | 8 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Peripheral Embolism | 2 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Peripheral Vascular Disease | 13 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Prior carotid artery stenting | 0 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Prior carotid endarterectomy | 1 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Prior stent | 0 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Prior surgical repair | 0 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Raynauds Phenomenon | 0 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Stroke | 0 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Thoracic Aortic Aneurysm | 1 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Thromboangiitis obliterans | 0 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Thrombophlebitis | 0 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Transient Ischemic attacks | 4 Participants |
| Peripheral Vascular, Stroke, and Aneurysm History Varicose Veins | 1 Participants |
| Psychosocial History Alcohol | 3 Participants |
| Psychosocial History Depression | 7 Participants |
| Psychosocial History Illicit drugs | 0 Participants |
| Psychosocial History Other | 4 Participants |
| Psychosocial History Prior substance abuse | 1 Participants |
| Pulmonary History Asthma | 5 Participants |
| Pulmonary History COPD | 27 Participants |
| Pulmonary History Mechanical ventilation >24 hours | 0 Participants |
| Pulmonary History Obstructive sleep apnea | 14 Participants |
| Pulmonary History Other | 16 Participants |
| Pulmonary History Pneumonia | 4 Participants |
| Pulmonary History Pulmonary Edema | 0 Participants |
| Pulmonary History Pulmonary Embolism | 4 Participants |
| Pulmonary History Respiratory depression or failure | 0 Participants |
| Pulmonary History Tobacco Use (Current) | 15 Participants |
| Pulmonary History Tobacco Use (former) | 56 Participants |
| Race/Ethnicity, Customized Black or African American/not Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Unknown/Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Unknown/not Hispanic or Latino | 11 Participants |
| Race/Ethnicity, Customized Unknown/Unknown | 3 Participants |
| Race/Ethnicity, Customized White/Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized White/not Hispanic or Latino | 58 Participants |
| Region of Enrollment United States | 75 Participants |
| Right Ankle Brachial Index | 1 ratio STANDARD_DEVIATION 0 |
| Right Distal Iliac Diameter Average | 16.5 mm STANDARD_DEVIATION 3.9 |
| Right Distal Iliac Diameter Maximum | 17.1 mm STANDARD_DEVIATION 4 |
| Right Distal Iliac Diameter Minimum | 15.8 mm STANDARD_DEVIATION 3.8 |
| Right distal iliac landing zone | 50.1 mm STANDARD_DEVIATION 20.7 |
| Right external iliac diameter Average | 8.1 mm STANDARD_DEVIATION 1.5 |
| Right external iliac diameter Maximum | 8.7 mm STANDARD_DEVIATION 1.6 |
| Right external iliac diameter Minimum | 7.6 mm STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 70 Participants |
| SIR Calcification Grade Calcification 0% of circumference | 14 Participants |
| SIR Calcification Grade Calcification 25-50% of circumference | 11 Participants |
| SIR Calcification Grade Calcification <25% of circumference | 49 Participants |
| SIR Calcification Grade Calcification >50% of circumference | 1 Participants |
| SIR Thrombus Grade Thrombus 0% of circumference | 27 Participants |
| SIR Thrombus Grade Thrombus 25-50% of circumference | 18 Participants |
| SIR Thrombus Grade Thrombus <25% of circumference | 16 Participants |
| SIR Thrombus Grade Thrombus >50% of circumference | 14 Participants |
| Transverse dimension of adjacent normal aortic segment | 22.7 mm STANDARD_DEVIATION 4.1 |
| Weight | 95 kilograms STANDARD_DEVIATION 19 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 75 |
| other Total, other adverse events | 54 / 75 |
| serious Total, serious adverse events | 11 / 75 |
Outcome results
Primary
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.
Time frame: 12 months
Population: 61 subjects were evaluable at 1 year- evaluable meaning able to be assessed for all items of composite endpoint of treatment success; 67 subjects completed 1 year, however, some of these subjects did not have imaging or imaging was not evaluable.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Number of Subjects With Treatment Success | 58 Participants |
Secondary
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
Time frame: 30 days, Day 31-365
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Blood and lymphatic System Disorder | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Cardiac Disorder | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Ear and Labyrinth Disorders | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Gastrointestinal Disorders | 4 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : General Disorders and Administration Site Conditions | 13 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Hepatobiliary Disorders | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Immune System Disorder | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Infections and Infestations | 5 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Injury, Poisoning and Procedural Complications | 5 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Musculoskeletal and Connective Tissue Disorders | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps) | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Nervous System Disorders | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Other | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Product Issues | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Psychiatric Disorders | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Renal and Urinary Disorders | 4 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Respiratory, Thoracic and Mediastinal Disorders | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | 30 days : Vascular Disorders | 7 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Blood and lymphatic System Disorder | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Cardiac Disorder | 11 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Ear and Labyrinth Disorders | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Gastrointestinal Disorders | 3 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : General Disorders and Administration Site Conditions | 15 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Hepatobiliary Disorders | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Immune System Disorder | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Infections and Infestations | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Injury, Poisoning and Procedural Complications | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Musculoskeletal and Connective Tissue Disorders | 7 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps) | 4 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Nervous System Disorders | 3 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Other | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Product Issues | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Psychiatric Disorders | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Renal and Urinary Disorders | 4 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Respiratory, Thoracic and Mediastinal Disorders | 3 Participants |
| Ovation Alto Abdominal Stent Graft System | Adverse Events (Serious and Non-serious) | Day 31-365 : Vascular Disorders | 9 Participants |
Secondary
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
Time frame: 30 days, Day 31-365
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Device-related Adverse Events (AEs) | 30 days : Infections and Infestations | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Device-related Adverse Events (AEs) | 30 days : Product Issues | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Device-related Adverse Events (AEs) | Day 31-365 : Infections and Infestations | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Device-related Adverse Events (AEs) | Day 31-365 : Product Issues | 0 Participants |
Secondary
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.
Time frame: 1 month, 6 months, 12 months
Population: All available data has been analyzed; due to imagining requirements and quality of imaging, all patients present for visit may not have been evaluable per definitions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 month : Type Ib | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 month : Type I | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 month : Type Ia | 1 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 month : Type II | 34 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 month : Type III | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 month : Type IIIA | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 month : Type IIIB | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 month : Type IV | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 month : Unknown | 3 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 6 month : Type I | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 6 month : Type Ia | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 year : Type Ia | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 6 month : Type Ib | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 6 month : Type II | 30 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 6 month : Type III | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 6 month : Type IIIA | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 6 month : Type IIIB | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 6 month : Type IV | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 6 month : Unknown | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 year : Type I | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 year : Type Ib | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 year : Type II | 25 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 year : Type III | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 year : Type IIIA | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 year : Type IIIB | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 year : Type IV | 0 endoleaks |
| Ovation Alto Abdominal Stent Graft System | Event Rates for Endoleaks | 1 year : Unknown | 2 endoleaks |
Secondary
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)
Time frame: 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Deaths : 30 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Deaths : 31-365 days | 3 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Bowel Ischemia : 30 days | 3 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Bowel Ischemia : 31-365 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Myocardial Infarction : 30 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Myocardial Infarction : 31-365 days | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Paralysis : 30 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Paralysis : 31-365 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Renal Failure : 30 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Renal Failure : 31-365 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Respiratory Failure : 30 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Respiratory Failure : 31-365 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Stroke : 30 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Stroke : 31-365 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Procedural Blood Loss >1000cc : 30 days | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Major Adverse Events | Procedural Blood Loss >1000cc : 31-365 days | 0 Participants |
Secondary
Number of Participants With AAA Enlargement > 5mm
Change in aneurysm diameter greater than 5mm
Time frame: 6 months, 12 months
Population: Subjects lost to follow-up withdrawn, death, or imaging not available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Number of Participants With AAA Enlargement > 5mm | 6 months | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Participants With AAA Enlargement > 5mm | 12 months | 1 Participants |
Secondary
Number of Participants With AAA-related Mortality
death caused by or related to AAA
Time frame: 1 month, Day 31-365
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Number of Participants With AAA-related Mortality | 30 days | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Participants With AAA-related Mortality | Day 31 to 365 | 0 Participants |
Secondary
Number of Participants With AAA Rupture
A tear in the abdominal aorta that can result in serious internal bleeding.
Time frame: 30 day, Day 31-365
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Number of Participants With AAA Rupture | 1 month | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Participants With AAA Rupture | Day 31-365 | 0 Participants |
Secondary
Number of Participants With Conversion to Open Repair
conversion to open abdominal surgery to repair AAA
Time frame: 30 day, Day 31-365
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Conversion to Open Repair | 30 day | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Conversion to Open Repair | Day 31 to 365 | 1 Participants |
Secondary
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.
Time frame: 1 month, 6 months, 12 months
Population: Imaging not available for every subject at every timepoint
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression) | 1 Month | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression) | 6 Months | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression) | 1 Year | 0 Participants |
Secondary
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.
Time frame: 1 month, 6 months, 12 months
Population: Subjects lost to follow-up withdrawn, death, or imaging not available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Stent Fracture | 1 month | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Stent Fracture | 6 months | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Stent Fracture | 12 months | 0 Participants |
Secondary
Number of Participants With Stent Graft Migration > 10mm
any change of stent graft migration (movement) greater than 10mm
Time frame: 6 months, 12 months
Population: Analysis based on all data available; imaging not available for all subjects to determine migration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Stent Graft Migration > 10mm | 6 Months | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Participants With Stent Graft Migration > 10mm | 1 Year | 0 Participants |
Secondary
Number of Secondary Interventions
Intervention occurring after index procedure and having to do with device or AAA.
Time frame: 30 days, Day 31-365
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Number of Secondary Interventions | 1 month | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Number of Secondary Interventions | Day 31 - 365 | 2 Participants |
Secondary
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
Time frame: 30 days, Day 31-365
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | Day 31-365 : Product Issues | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | 30 days : General Disorders and Administration Site Conditions | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | 30 days : Gastrointestinal Disorders | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | 30 days : Injury Poisoning and Procedural Complications | 3 Participants |
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | 30 days : Product Issues | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | 30 days : Vascular Disorders | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | Day 31-365 : Gastrointestinal Disorders | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | Day 31-365 : General Disorders and Administration Site Conditions | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | Day 31-365 : Injury Poisoning and Procedural Complications | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Procedure-related Adverse Event | Day 31-365 : Vascular Disorders | 1 Participants |
Secondary
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
Time frame: 30 Days, Day31-365)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | 30 days : Cardiac disorders | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | 30 days : Gastrointestinal Disorders | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | 30 days : Infections and Infestations | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | Day 31-365 : Vascular Disorders | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | 30 days : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps) | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | 30 days : Nervous System Disorders | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | 30 days : Product Issues | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | 30 days : Vascular Disorders | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | 30 days : Injury, Poisoning and Procedural Complications | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | Day 31-365 : Cardiac disorders | 2 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | Day 31-365 : Gastrointestinal Disorders | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | Day 31-365 : Infections and Infestations | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | Day 31-365 : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps) | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | Day 31-365 : Nervous System Disorders | 1 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | Day 31-365 : Product Issues | 0 Participants |
| Ovation Alto Abdominal Stent Graft System | Serious Adverse Event | Day 31-365 : Injury, Poisoning and Procedural Complications | 0 Participants |