Trial Outcomes & Findings for Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study (NCT NCT02949297)
NCT ID: NCT02949297
Last Updated: 2021-12-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
12 months
Results posted on
2021-12-22
Participant Flow
Participant milestones
| Measure |
Ovation Alto Abdominal Stent Graft System
Endovascular repair of abdominal aortic aneurysm (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
|
|---|---|
|
1 Month
STARTED
|
75
|
|
1 Month
COMPLETED
|
75
|
|
1 Month
NOT COMPLETED
|
0
|
|
6 Months
STARTED
|
75
|
|
6 Months
COMPLETED
|
72
|
|
6 Months
NOT COMPLETED
|
3
|
|
12 Months
STARTED
|
72
|
|
12 Months
COMPLETED
|
67
|
|
12 Months
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data point only provided for 73 out of 75 subjects. Reason is unknown why this information was not provided for 2 out of 75 subjects
Baseline characteristics by cohort
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
68 Participants
n=75 Participants
|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 7 • n=75 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
White/not Hispanic or Latino
|
58 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
White/Hispanic or Latino
|
1 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Black or African American/not Hispanic or Latino
|
1 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Unknown/not Hispanic or Latino
|
11 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Unknown/Hispanic or Latino
|
1 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Unknown/Unknown
|
3 Participants
n=75 Participants
|
|
Region of Enrollment
United States
|
75 Participants
n=75 Participants
|
|
Left Ankle Brachial Index
|
1 ratio
STANDARD_DEVIATION 0 • n=73 Participants • Data point only provided for 73 out of 75 subjects. Reason is unknown why this information was not provided for 2 out of 75 subjects
|
|
Right Ankle Brachial Index
|
1 ratio
STANDARD_DEVIATION 0 • n=72 Participants • Data point only provided for 72 out of 75 subjects. Reason is unknown why this information was not provided for 3 out of 75 subjects
|
|
ASA Class
Class 1/2
|
5 Participants
n=75 Participants
|
|
ASA Class
Class 3/4
|
70 Participants
n=75 Participants
|
|
Height
|
179 cm
STANDARD_DEVIATION 9 • n=75 Participants
|
|
Weight
|
95 kilograms
STANDARD_DEVIATION 19 • n=75 Participants
|
|
Calculated BMI
|
30 kg/m^2
STANDARD_DEVIATION 5 • n=75 Participants
|
|
Cardiovascular History
Coronary Artery Disease
|
35 Participants
n=75 Participants
|
|
Cardiovascular History
Prior PTCA
|
3 Participants
n=75 Participants
|
|
Cardiovascular History
Prior CABG
|
5 Participants
n=75 Participants
|
|
Cardiovascular History
Stents
|
7 Participants
n=75 Participants
|
|
Cardiovascular History
Valvular Heart Disease
|
11 Participants
n=75 Participants
|
|
Cardiovascular History
Prior Valve Repair
|
0 Participants
n=75 Participants
|
|
Cardiovascular History
Prior Valve Replacement
|
2 Participants
n=75 Participants
|
|
Cardiovascular History
Angina pectoris or chest discomfort
|
5 Participants
n=75 Participants
|
|
Cardiovascular History
Cardiomyopathy
|
3 Participants
n=75 Participants
|
|
Cardiovascular History
Congestive Heart Failure
|
6 Participants
n=75 Participants
|
|
Cardiovascular History
Myocardial Infarction
|
11 Participants
n=75 Participants
|
|
Cardiovascular History
Arrhythmia
|
17 Participants
n=75 Participants
|
|
Cardiovascular History
Pacemaker
|
3 Participants
n=75 Participants
|
|
Cardiovascular History
ICD
|
1 Participants
n=75 Participants
|
|
Cardiovascular History
AICD
|
0 Participants
n=75 Participants
|
|
Cardiovascular History
Anticoagulant medication
|
7 Participants
n=75 Participants
|
|
Cardiovascular History
Hypertension
|
62 Participants
n=75 Participants
|
|
Cardiovascular History
Hypotension
|
0 Participants
n=75 Participants
|
|
Cardiovascular History
Hyperlipidemia
|
57 Participants
n=75 Participants
|
|
Cardiovascular History
Other
|
10 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Peripheral Vascular Disease
|
13 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Atherosclerosis
|
8 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Thromboangiitis obliterans
|
0 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Chronic Venous Insufficiency
|
2 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Claudication
|
4 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Deep Venous Thrombosis
|
3 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Peripheral Embolism
|
2 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Raynauds Phenomenon
|
0 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Thrombophlebitis
|
0 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Varicose Veins
|
1 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Prior surgical repair
|
0 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Prior stent
|
0 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Carotid artery disease
|
6 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Prior carotid artery stenting
|
0 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Prior carotid endarterectomy
|
1 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Transient Ischemic attacks
|
4 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Stroke
|
0 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Aneurysms
|
75 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Abdominal Aortic Aneurysm
|
75 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Cerebral Aneurysm
|
0 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Thoracic Aortic Aneurysm
|
1 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Family History of Aneurysms
|
9 Participants
n=75 Participants
|
|
Peripheral Vascular, Stroke, and Aneurysm History
Other
|
8 Participants
n=75 Participants
|
|
Pulmonary History
COPD
|
27 Participants
n=75 Participants
|
|
Pulmonary History
Asthma
|
5 Participants
n=75 Participants
|
|
Pulmonary History
Pneumonia
|
4 Participants
n=75 Participants
|
|
Pulmonary History
Pulmonary Edema
|
0 Participants
n=75 Participants
|
|
Pulmonary History
Pulmonary Embolism
|
4 Participants
n=75 Participants
|
|
Pulmonary History
Respiratory depression or failure
|
0 Participants
n=75 Participants
|
|
Pulmonary History
Mechanical ventilation >24 hours
|
0 Participants
n=75 Participants
|
|
Pulmonary History
Obstructive sleep apnea
|
14 Participants
n=75 Participants
|
|
Pulmonary History
Tobacco Use (Current)
|
15 Participants
n=75 Participants
|
|
Pulmonary History
Tobacco Use (former)
|
56 Participants
n=75 Participants
|
|
Pulmonary History
Other
|
16 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Renal Insufficiency
|
5 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Receiving any form of dialysis
|
0 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Chronic Renal Failure
|
0 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Renal Microemboli
|
0 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Chronic urinary tract infections
|
1 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Incontinence bladder problems
|
3 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Gastrointestinal bleeding
|
2 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Bowel ischemia
|
0 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Bowel obstruction
|
1 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Bowel fistulas
|
0 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Paralytic or adynamic ileus
|
0 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Impotence including erectile dysfunction
|
8 Participants
n=75 Participants
|
|
Gastrointestinal, Genitourinary, Reproductive History
Other
|
42 Participants
n=75 Participants
|
|
Neurological History
Reversible Ischemic Neurologic Disease
|
0 Participants
n=75 Participants
|
|
Neurological History
Paraplegia
|
0 Participants
n=75 Participants
|
|
Neurological History
Parasthesia
|
1 Participants
n=75 Participants
|
|
Neurological History
Chronic Back Pain
|
18 Participants
n=75 Participants
|
|
Neurological History
Chronic Headaches, Migraines
|
3 Participants
n=75 Participants
|
|
Neurological History
Other
|
20 Participants
n=75 Participants
|
|
Endocrine History
Diabetes Type I
|
0 Participants
n=75 Participants
|
|
Endocrine History
Diabetes Type II
|
22 Participants
n=75 Participants
|
|
Endocrine History
Diabetic incompressible vessels
|
0 Participants
n=75 Participants
|
|
Endocrine History
Immunodeficiency
|
2 Participants
n=75 Participants
|
|
Endocrine History
Hyperthyroidism or Hypothyroidism
|
8 Participants
n=75 Participants
|
|
Endocrine History
Other
|
5 Participants
n=75 Participants
|
|
Hematological History
Hemorrhage
|
0 Participants
n=75 Participants
|
|
Hematological History
Coagulopathy disorder
|
0 Participants
n=75 Participants
|
|
Hematological History
Anemia
|
5 Participants
n=75 Participants
|
|
Hematological History
Platelet Disorder
|
0 Participants
n=75 Participants
|
|
Hematological History
Other
|
5 Participants
n=75 Participants
|
|
Psychosocial History
Depression
|
7 Participants
n=75 Participants
|
|
Psychosocial History
Prior substance abuse
|
1 Participants
n=75 Participants
|
|
Psychosocial History
Alcohol
|
3 Participants
n=75 Participants
|
|
Psychosocial History
Illicit drugs
|
0 Participants
n=75 Participants
|
|
Psychosocial History
Other
|
4 Participants
n=75 Participants
|
|
Miscellaneous Medical History
Connective Tissue Disorder
|
0 Participants
n=75 Participants
|
|
Miscellaneous Medical History
Allergy, Intolerance to PTFE, polymers, FEP, nitinol
|
0 Participants
n=75 Participants
|
|
Miscellaneous Medical History
Hypersensitivity to anticoagulation, contrast
|
0 Participants
n=75 Participants
|
|
Miscellaneous Medical History
Cancer
|
14 Participants
n=75 Participants
|
|
Miscellaneous Medical History
Liver Disease
|
5 Participants
n=75 Participants
|
|
Miscellaneous Medical History
Other significant medical, surgical history
|
26 Participants
n=75 Participants
|
|
Juxtarenal angle
|
23.1 degrees
STANDARD_DEVIATION 18.7 • n=75 Participants
|
|
Aortic diameter Inferior Renal -35mm
Minimum
|
25.0 mm
STANDARD_DEVIATION 2.3 • n=75 Participants
|
|
Aortic diameter Inferior Renal -35mm
Maximum
|
26.6 mm
STANDARD_DEVIATION 2.4 • n=75 Participants
|
|
Aortic diameter Inferior Renal -35mm
Average
|
25.9 mm
STANDARD_DEVIATION 2.3 • n=75 Participants
|
|
Aortic diameter inferior renal
Minimum
|
21.8 mm
STANDARD_DEVIATION 2.5 • n=75 Participants
|
|
Aortic diameter inferior renal
Maximum
|
23.2 mm
STANDARD_DEVIATION 2.6 • n=75 Participants
|
|
Aortic diameter inferior renal
Average
|
22.5 mm
STANDARD_DEVIATION 2.5 • n=75 Participants
|
|
Aortic diameter inferior renal +7mm
Minimum
|
21.8 mm
STANDARD_DEVIATION 2.3 • n=75 Participants
|
|
Aortic diameter inferior renal +7mm
Maximum
|
23.0 mm
STANDARD_DEVIATION 2.7 • n=75 Participants
|
|
Aortic diameter inferior renal +7mm
Average
|
22.4 mm
STANDARD_DEVIATION 2.4 • n=75 Participants
|
|
Change from diameter at inferior renal artery to inferior renal artery diameter at +7mm
|
0.0 %
STANDARD_DEVIATION 7.2 • n=75 Participants
|
|
Aortic diameter inferior renal +10mm
Minimum
|
21.8 mm
STANDARD_DEVIATION 2.5 • n=75 Participants
|
|
Aortic diameter inferior renal +10mm
Maximum
|
23.4 mm
STANDARD_DEVIATION 2.8 • n=75 Participants
|
|
Aortic diameter inferior renal +10mm
Average
|
22.6 mm
STANDARD_DEVIATION 2.5 • n=75 Participants
|
|
Maximum Sac Diameter
<40 mm
|
4 Participants
n=75 Participants
|
|
Maximum Sac Diameter
≥40, <50 mm
|
23 Participants
n=75 Participants
|
|
Maximum Sac Diameter
≥ 50, <60 mm
|
40 Participants
n=75 Participants
|
|
Maximum Sac Diameter
≥ 60 mm
|
8 Participants
n=75 Participants
|
|
Native Bifurcation
Minimum
|
20.1 mm
STANDARD_DEVIATION 5.1 • n=74 Participants • Data point only provided for 74 of 75 subjects.
|
|
Native Bifurcation
Maximum
|
26.2 mm
STANDARD_DEVIATION 6.7 • n=74 Participants • Data point only provided for 74 of 75 subjects.
|
|
Transverse dimension of adjacent normal aortic segment
|
22.7 mm
STANDARD_DEVIATION 4.1 • n=75 Participants
|
|
Neck Length
|
27.9 mm
STANDARD_DEVIATION 13.7 • n=75 Participants
|
|
Distance from the most distal renal artery to most superior left internal iliac artery
|
182.5 mm
STANDARD_DEVIATION 24.7 • n=75 Participants
|
|
Distance from the most distal renal artery to most superior right internal iliac artery (mm) 75 181.
|
181.2 mm
STANDARD_DEVIATION 21.0 • n=75 Participants
|
|
Inferior Renal to Aortic Bifurcation
|
110.9 mm
STANDARD_DEVIATION 13.1 • n=75 Participants
|
|
Right Distal Iliac Diameter
Minimum
|
15.8 mm
STANDARD_DEVIATION 3.8 • n=75 Participants
|
|
Right Distal Iliac Diameter
Maximum
|
17.1 mm
STANDARD_DEVIATION 4.0 • n=75 Participants
|
|
Right Distal Iliac Diameter
Average
|
16.5 mm
STANDARD_DEVIATION 3.9 • n=75 Participants
|
|
Right external iliac diameter
Minimum
|
7.6 mm
STANDARD_DEVIATION 1.6 • n=75 Participants
|
|
Right external iliac diameter
Maximum
|
8.7 mm
STANDARD_DEVIATION 1.6 • n=75 Participants
|
|
Right external iliac diameter
Average
|
8.1 mm
STANDARD_DEVIATION 1.5 • n=75 Participants
|
|
Left distal iliac diameter
Minimum
|
15.1 mm
STANDARD_DEVIATION 3.0 • n=75 Participants
|
|
Left distal iliac diameter
Maximum
|
16.4 mm
STANDARD_DEVIATION 3.3 • n=75 Participants
|
|
Left distal iliac diameter
Average
|
15.8 mm
STANDARD_DEVIATION 3.1 • n=75 Participants
|
|
Left external iliac diameter
Minimum
|
7.6 mm
STANDARD_DEVIATION 1.9 • n=75 Participants
|
|
Left external iliac diameter
Maximum
|
8.7 mm
STANDARD_DEVIATION 1.6 • n=75 Participants
|
|
Left external iliac diameter
Average
|
8.2 mm
STANDARD_DEVIATION 1.7 • n=75 Participants
|
|
Left distal iliac landing zone
|
49.1 mm
STANDARD_DEVIATION 18.7 • n=75 Participants
|
|
Right distal iliac landing zone
|
50.1 mm
STANDARD_DEVIATION 20.7 • n=75 Participants
|
|
SIR Calcification Grade
Calcification 0% of circumference
|
14 Participants
n=75 Participants
|
|
SIR Calcification Grade
Calcification <25% of circumference
|
49 Participants
n=75 Participants
|
|
SIR Calcification Grade
Calcification 25-50% of circumference
|
11 Participants
n=75 Participants
|
|
SIR Calcification Grade
Calcification >50% of circumference
|
1 Participants
n=75 Participants
|
|
SIR Thrombus Grade
Thrombus 0% of circumference
|
27 Participants
n=75 Participants
|
|
SIR Thrombus Grade
Thrombus <25% of circumference
|
16 Participants
n=75 Participants
|
|
SIR Thrombus Grade
Thrombus 25-50% of circumference
|
18 Participants
n=75 Participants
|
|
SIR Thrombus Grade
Thrombus >50% of circumference
|
14 Participants
n=75 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=61 Participants
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
|
|---|---|
|
Number of Subjects With Treatment Success
|
58 Participants
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Event Rates for Endoleaks
1 month : Type III
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 month : Type IIIB
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 month : Unknown
|
3 endoleaks
|
|
Event Rates for Endoleaks
6 month : Type II
|
30 endoleaks
|
|
Event Rates for Endoleaks
6 month : Type IIIB
|
0 endoleaks
|
|
Event Rates for Endoleaks
6 month : Unknown
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 year : Type IIIA
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 year : Type IIIB
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 year : Type IV
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 year : Unknown
|
2 endoleaks
|
|
Event Rates for Endoleaks
1 month : Type I
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 month : Type Ia
|
1 endoleaks
|
|
Event Rates for Endoleaks
1 month : Type Ib
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 month : Type II
|
34 endoleaks
|
|
Event Rates for Endoleaks
1 month : Type IIIA
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 month : Type IV
|
0 endoleaks
|
|
Event Rates for Endoleaks
6 month : Type I
|
0 endoleaks
|
|
Event Rates for Endoleaks
6 month : Type Ia
|
0 endoleaks
|
|
Event Rates for Endoleaks
6 month : Type Ib
|
0 endoleaks
|
|
Event Rates for Endoleaks
6 month : Type III
|
0 endoleaks
|
|
Event Rates for Endoleaks
6 month : Type IIIA
|
0 endoleaks
|
|
Event Rates for Endoleaks
6 month : Type IV
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 year : Type I
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 year : Type Ia
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 year : Type Ib
|
0 endoleaks
|
|
Event Rates for Endoleaks
1 year : Type II
|
25 endoleaks
|
|
Event Rates for Endoleaks
1 year : Type III
|
0 endoleaks
|
SECONDARY outcome
Timeframe: 6 months, 12 monthsPopulation: Analysis based on all data available; imaging not available for all subjects to determine migration.
any change of stent graft migration (movement) greater than 10mm
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=71 Participants
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
|
|---|---|
|
Number of Participants With Stent Graft Migration > 10mm
6 Months
|
0 Participants
|
|
Number of Participants With Stent Graft Migration > 10mm
1 Year
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 monthsPopulation: Subjects lost to follow-up withdrawn, death, or imaging not available.
Change in aneurysm diameter greater than 5mm
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=72 Participants
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
|
|---|---|
|
Number of Participants With AAA Enlargement > 5mm
6 months
|
0 Participants
|
|
Number of Participants With AAA Enlargement > 5mm
12 months
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 day, Day 31-365A tear in the abdominal aorta that can result in serious internal bleeding.
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Number of Participants With AAA Rupture
1 month
|
0 Participants
|
|
Number of Participants With AAA Rupture
Day 31-365
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 day, Day 31-365conversion to open abdominal surgery to repair AAA
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Number of Participants With Conversion to Open Repair
30 day
|
0 Participants
|
|
Number of Participants With Conversion to Open Repair
Day 31 to 365
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days, Day 31-365Intervention occurring after index procedure and having to do with device or AAA.
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Number of Secondary Interventions
1 month
|
0 Participants
|
|
Number of Secondary Interventions
Day 31 - 365
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 month, Day 31-365death caused by or related to AAA
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Number of Participants With AAA-related Mortality
30 days
|
0 Participants
|
|
Number of Participants With AAA-related Mortality
Day 31 to 365
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, Day 31-365Device-Related: Event is caused or contributed by any component of the device during delivery, deployment or while the device is in situ post-operatively
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Device-related Adverse Events (AEs)
30 days : Infections and Infestations
|
0 Participants
|
|
Device-related Adverse Events (AEs)
30 days : Product Issues
|
1 Participants
|
|
Device-related Adverse Events (AEs)
Day 31-365 : Infections and Infestations
|
1 Participants
|
|
Device-related Adverse Events (AEs)
Day 31-365 : Product Issues
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearMajor 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)
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Major Adverse Events
Bowel Ischemia : 30 days
|
3 Participants
|
|
Major Adverse Events
Paralysis : 30 days
|
0 Participants
|
|
Major Adverse Events
Paralysis : 31-365 days
|
0 Participants
|
|
Major Adverse Events
Renal Failure : 31-365 days
|
0 Participants
|
|
Major Adverse Events
Respiratory Failure : 30 days
|
0 Participants
|
|
Major Adverse Events
Deaths : 30 days
|
0 Participants
|
|
Major Adverse Events
Deaths : 31-365 days
|
3 Participants
|
|
Major Adverse Events
Bowel Ischemia : 31-365 days
|
0 Participants
|
|
Major Adverse Events
Myocardial Infarction : 30 days
|
0 Participants
|
|
Major Adverse Events
Myocardial Infarction : 31-365 days
|
1 Participants
|
|
Major Adverse Events
Renal Failure : 30 days
|
0 Participants
|
|
Major Adverse Events
Respiratory Failure : 31-365 days
|
0 Participants
|
|
Major Adverse Events
Stroke : 30 days
|
0 Participants
|
|
Major Adverse Events
Stroke : 31-365 days
|
0 Participants
|
|
Major Adverse Events
Procedural Blood Loss >1000cc : 30 days
|
1 Participants
|
|
Major Adverse Events
Procedural Blood Loss >1000cc : 31-365 days
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 monthsPopulation: Imaging not available for every subject at every timepoint
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.
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=74 Participants
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
|
|---|---|
|
Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)
1 Month
|
0 Participants
|
|
Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)
6 Months
|
0 Participants
|
|
Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)
1 Year
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 monthsPopulation: Subjects lost to follow-up withdrawn, death, or imaging not available.
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.
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=70 Participants
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
|
|---|---|
|
Number of Participants With Stent Fracture
1 month
|
0 Participants
|
|
Number of Participants With Stent Fracture
6 months
|
0 Participants
|
|
Number of Participants With Stent Fracture
12 months
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, Day 31-365An 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
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Adverse Events (Serious and Non-serious)
30 days : Blood and lymphatic System Disorder
|
0 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Cardiac Disorder
|
0 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Ear and Labyrinth Disorders
|
0 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Musculoskeletal and Connective Tissue Disorders
|
1 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps)
|
0 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Nervous System Disorders
|
1 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : General Disorders and Administration Site Conditions
|
15 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Hepatobiliary Disorders
|
2 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Immune System Disorder
|
1 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Infections and Infestations
|
2 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Injury, Poisoning and Procedural Complications
|
2 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Musculoskeletal and Connective Tissue Disorders
|
7 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps)
|
4 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Psychiatric Disorders
|
0 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Renal and Urinary Disorders
|
4 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Gastrointestinal Disorders
|
4 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : General Disorders and Administration Site Conditions
|
13 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Hepatobiliary Disorders
|
0 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Immune System Disorder
|
2 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Infections and Infestations
|
5 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Injury, Poisoning and Procedural Complications
|
5 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Other
|
2 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Product Issues
|
1 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Psychiatric Disorders
|
1 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Renal and Urinary Disorders
|
4 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Respiratory, Thoracic and Mediastinal Disorders
|
2 Participants
|
|
Adverse Events (Serious and Non-serious)
30 days : Vascular Disorders
|
7 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Blood and lymphatic System Disorder
|
2 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Cardiac Disorder
|
11 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Ear and Labyrinth Disorders
|
1 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Gastrointestinal Disorders
|
3 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Nervous System Disorders
|
3 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Other
|
2 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Product Issues
|
0 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Respiratory, Thoracic and Mediastinal Disorders
|
3 Participants
|
|
Adverse Events (Serious and Non-serious)
Day 31-365 : Vascular Disorders
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 days, Day 31-365Procedure-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
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Procedure-related Adverse Event
Day 31-365 : General Disorders and Administration Site Conditions
|
2 Participants
|
|
Procedure-related Adverse Event
Day 31-365 : Injury Poisoning and Procedural Complications
|
0 Participants
|
|
Procedure-related Adverse Event
Day 31-365 : Product Issues
|
0 Participants
|
|
Procedure-related Adverse Event
Day 31-365 : Vascular Disorders
|
1 Participants
|
|
Procedure-related Adverse Event
30 days : Gastrointestinal Disorders
|
2 Participants
|
|
Procedure-related Adverse Event
30 days : General Disorders and Administration Site Conditions
|
0 Participants
|
|
Procedure-related Adverse Event
30 days : Injury Poisoning and Procedural Complications
|
3 Participants
|
|
Procedure-related Adverse Event
30 days : Product Issues
|
1 Participants
|
|
Procedure-related Adverse Event
30 days : Vascular Disorders
|
0 Participants
|
|
Procedure-related Adverse Event
Day 31-365 : Gastrointestinal Disorders
|
0 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 Participants
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
|
|---|---|
|
Serious Adverse Event
30 days : Nervous System Disorders
|
0 Participants
|
|
Serious Adverse Event
Day 31-365 : Infections and Infestations
|
1 Participants
|
|
Serious Adverse Event
Day 31-365 : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps)
|
1 Participants
|
|
Serious Adverse Event
Day 31-365 : Nervous System Disorders
|
1 Participants
|
|
Serious Adverse Event
30 days : Cardiac disorders
|
0 Participants
|
|
Serious Adverse Event
30 days : Gastrointestinal Disorders
|
2 Participants
|
|
Serious Adverse Event
30 days : Infections and Infestations
|
0 Participants
|
|
Serious Adverse Event
30 days : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps)
|
0 Participants
|
|
Serious Adverse Event
30 days : Product Issues
|
1 Participants
|
|
Serious Adverse Event
30 days : Vascular Disorders
|
0 Participants
|
|
Serious Adverse Event
30 days : Injury, Poisoning and Procedural Complications
|
2 Participants
|
|
Serious Adverse Event
Day 31-365 : Cardiac disorders
|
2 Participants
|
|
Serious Adverse Event
Day 31-365 : Gastrointestinal Disorders
|
0 Participants
|
|
Serious Adverse Event
Day 31-365 : Product Issues
|
0 Participants
|
|
Serious Adverse Event
Day 31-365 : Vascular Disorders
|
1 Participants
|
|
Serious Adverse Event
Day 31-365 : Injury, Poisoning and Procedural Complications
|
0 Participants
|
Adverse Events
Ovation Alto Abdominal Stent Graft System
Serious events: 11 serious events
Other events: 54 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Bowel Ischemia
|
4.0%
3/75 • AEs were collected over 1 year.
|
|
Product Issues
Endoleak Ia
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
Aneurysm Expansion
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Injury, poisoning and procedural complications
Procedural Blood Loss
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Infections and infestations
Device Infection
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Nervous system disorders
Other
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Unknown Cause of Death
|
1.3%
1/75 • AEs were collected over 1 year.
|
Other adverse events
| Measure |
Ovation Alto Abdominal Stent Graft System
n=75 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
2.7%
2/75 • AEs were collected over 1 year.
|
|
Renal and urinary disorders
Acute Renal Failure
|
2.7%
2/75 • AEs were collected over 1 year.
|
|
Gastrointestinal disorders
Adynamic Ileus
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Angina
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
Anticoagulant Related Bleeding
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Arrhythmia
|
4.0%
3/75 • AEs were collected over 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Musculoskeletal and connective tissue disorders
Bone Fracture
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
Claudication
|
2.7%
2/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Congestive Heart Failure
|
4.0%
3/75 • AEs were collected over 1 year.
|
|
Infections and infestations
COPD
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Edema
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
Embolism
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
Endoleak IA
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
Endoleak II
|
36.0%
27/75 • AEs were collected over 1 year.
|
|
Vascular disorders
Hypertension
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
Hypotension
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Immune system disorders
Medication Reaction
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
Medication Reaction
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
Numbness
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Gastrointestinal disorders
Routine CT scan done for follow up of AAA stent graft repair
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
plaque obstructing true lumen (iliofemoral endarterectomy)
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Injury, poisoning and procedural complications
Hematuria
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Renal and urinary disorders
Blood in urine
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxemia
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Injury, poisoning and procedural complications
Sub-Dermal Hematoma
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Syncope (Cardiac)
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Nervous system disorders
Syncope (cardiac)
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Nervous system disorders
TIA
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Renal and urinary disorders
Urinary Retention
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Infections and infestations
UTI
|
4.0%
3/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Valve Disorder
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive lung disease
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
Proglide failure during surgical closure of left groin incision
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Renal and urinary disorders
Hematuria
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Injury, poisoning and procedural complications
degenerative changes to the body wall
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Nervous system disorders
Ulnar Mononeuropathy
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
Bilateral Popliteal Artery Aneurysms
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Nervous system disorders
Altered mental status
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Hypoxic Respiratory Failure
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
Thoracic Aortic Aneurysm
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Hepatobiliary disorders
Choledocholithiasis
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Immune system disorders
Gout
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Gastrointestinal disorders
diarrhea
|
2.7%
2/75 • AEs were collected over 1 year.
|
|
Injury, poisoning and procedural complications
decreased pulse in right foot
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Injury, poisoning and procedural complications
pain in the toes of the right foot
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in right foot with toe discoloration
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Infections and infestations
MRSA and Enterococcus of the right 4th toe
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Infections and infestations
left plank pain
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Musculoskeletal and connective tissue disorders
Severe osteoarthritis right hip
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Renal and urinary disorders
left testicular infarction
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Musculoskeletal and connective tissue disorders
left leg pain
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Injury, poisoning and procedural complications
Nausea
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Injury, poisoning and procedural complications
Post Implant Syndrome
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
Acute exacerbation of chronic lower back pain
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Immune system disorders
Polymyalgia Rheumatica
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Musculoskeletal and connective tissue disorders
Sciatica pain
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Musculoskeletal and connective tissue disorders
Right forearm bruising
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Psychiatric disorders
Encephalopathy
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left breast cancer
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Vascular disorders
carotid stenosis
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Musculoskeletal and connective tissue disorders
swelling of right leg below the knee
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colon cancer
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Hepatobiliary disorders
cholecystectomy
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Ear and labyrinth disorders
cataract surgery
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
head laceration (due to fall)
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Gastrointestinal disorders
constipation
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
right foot pain
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
benign lung nodule
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Hypovolemia
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Renal and urinary disorders
AKI on CKD
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Cardiac disorders
Left ventricular outflow tract obstruction
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
Sleeplessness due to PTSD
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Renal and urinary disorders
Prostatitis
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Gastrointestinal disorders
Esophageal Stricture
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
Hypokalemia
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
Injury, poisoning and procedural complications
air leak status post left lobectomy
|
1.3%
1/75 • AEs were collected over 1 year.
|
|
General disorders
Endoleak (unknown)
|
1.3%
1/75 • AEs were collected over 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI can publish institution's data/results 18 months after study conclusion at all sites or when multi-center results are published or notification that results will not be published. Institution is to submit drafts of manuscripts to Endologix 30 days prior to submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER