ELEVATE: Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
Sponsor
Endologix (Industry)
Overall Status
Completed
CT.gov ID
NCT02949297
Collaborator
(none)
75
13
1
23.2
5.8
0.2
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
Actual Study Start Date
:
Mar 30, 2017
Actual Primary Completion Date
:
Mar 6, 2019
Actual Study Completion Date
:
Mar 6, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Ovation Alto Abdominal Stent Graft System Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System. |
Device: Ovation Alto Abdominal Stent Graft System
Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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
- 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
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abrazo Arizona Heart Hospital | Phoenix | Arizona | United States | 85016 |
| 2 | VA San Diego | San Diego | California | United States | 92161 |
| 3 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 4 | Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 5 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 6 | New Mexico Heart Institute | Albuquerque | New Mexico | United States | 87102 |
| 7 | University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center | Buffalo | New York | United States | 14203 |
| 8 | Mission Hospital | Asheville | North Carolina | United States | 28801 |
| 9 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 10 | North Central Heart | Sioux Falls | South Dakota | United States | 57108 |
| 11 | Wellmont CVA Heart Institute | Kingsport | Tennessee | United States | 37660 |
| 12 | Baylor St. Luke's Medical Center | Houston | Texas | United States | 77030 |
| 13 | Swedish Heart and Vascular Research | Seattle | Washington | United States | 98122 |
Sponsors and Collaborators
- Endologix
Investigators
- Principal Investigator: Sean Lyden, MD, The Cleveland Clinic
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Endologix
ClinicalTrials.gov Identifier:
NCT02949297
Other Study ID Numbers:
- 771-0013
First Posted:
Oct 31, 2016
Last Update Posted:
Dec 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Endologix
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Period Title: 1 Month | |
| STARTED | 75 |
| COMPLETED | 75 |
| NOT COMPLETED | 0 |
| Period Title: 1 Month | |
| STARTED | 75 |
| COMPLETED | 72 |
| NOT COMPLETED | 3 |
| Period Title: 1 Month | |
| STARTED | 72 |
| COMPLETED | 67 |
| NOT COMPLETED | 5 |
Baseline Characteristics
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Overall Participants | 75 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
7
9.3%
|
| >=65 years |
68
90.7%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
73
(7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
5
6.7%
|
| Male |
70
93.3%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| White/not Hispanic or Latino |
58
77.3%
|
| White/Hispanic or Latino |
1
1.3%
|
| Black or African American/not Hispanic or Latino |
1
1.3%
|
| Unknown/not Hispanic or Latino |
11
14.7%
|
| Unknown/Hispanic or Latino |
1
1.3%
|
| Unknown/Unknown |
3
4%
|
| Region of Enrollment (Count of Participants) | |
| United States |
75
100%
|
| Left Ankle Brachial Index (ratio) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [ratio] |
1
(0)
|
| Right Ankle Brachial Index (ratio) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [ratio] |
1
(0)
|
| ASA Class (Count of Participants) | |
| Class 1/2 |
5
6.7%
|
| Class 3/4 |
70
93.3%
|
| Height (cm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [cm] |
179
(9)
|
| Weight (kilograms) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kilograms] |
95
(19)
|
| Calculated BMI (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
30
(5)
|
| Cardiovascular History (Count of Participants) | |
| Coronary Artery Disease |
35
46.7%
|
| Prior PTCA |
3
4%
|
| Prior CABG |
5
6.7%
|
| Stents |
7
9.3%
|
| Valvular Heart Disease |
11
14.7%
|
| Prior Valve Repair |
0
0%
|
| Prior Valve Replacement |
2
2.7%
|
| Angina pectoris or chest discomfort |
5
6.7%
|
| Cardiomyopathy |
3
4%
|
| Congestive Heart Failure |
6
8%
|
| Myocardial Infarction |
11
14.7%
|
| Arrhythmia |
17
22.7%
|
| Pacemaker |
3
4%
|
| ICD |
1
1.3%
|
| AICD |
0
0%
|
| Anticoagulant medication |
7
9.3%
|
| Hypertension |
62
82.7%
|
| Hypotension |
0
0%
|
| Hyperlipidemia |
57
76%
|
| Other |
10
13.3%
|
| Peripheral Vascular, Stroke, and Aneurysm History (Count of Participants) | |
| Peripheral Vascular Disease |
13
17.3%
|
| Atherosclerosis |
8
10.7%
|
| Thromboangiitis obliterans |
0
0%
|
| Chronic Venous Insufficiency |
2
2.7%
|
| Claudication |
4
5.3%
|
| Deep Venous Thrombosis |
3
4%
|
| Peripheral Embolism |
2
2.7%
|
| Raynauds Phenomenon |
0
0%
|
| Thrombophlebitis |
0
0%
|
| Varicose Veins |
1
1.3%
|
| Prior surgical repair |
0
0%
|
| Prior stent |
0
0%
|
| Carotid artery disease |
6
8%
|
| Prior carotid artery stenting |
0
0%
|
| Prior carotid endarterectomy |
1
1.3%
|
| Transient Ischemic attacks |
4
5.3%
|
| Stroke |
0
0%
|
| Aneurysms |
75
100%
|
| Abdominal Aortic Aneurysm |
75
100%
|
| Cerebral Aneurysm |
0
0%
|
| Thoracic Aortic Aneurysm |
1
1.3%
|
| Family History of Aneurysms |
9
12%
|
| Other |
8
10.7%
|
| Pulmonary History (Count of Participants) | |
| COPD |
27
36%
|
| Asthma |
5
6.7%
|
| Pneumonia |
4
5.3%
|
| Pulmonary Edema |
0
0%
|
| Pulmonary Embolism |
4
5.3%
|
| Respiratory depression or failure |
0
0%
|
| Mechanical ventilation >24 hours |
0
0%
|
| Obstructive sleep apnea |
14
18.7%
|
| Tobacco Use (Current) |
15
20%
|
| Tobacco Use (former) |
56
74.7%
|
| Other |
16
21.3%
|
| Gastrointestinal, Genitourinary, Reproductive History (Count of Participants) | |
| Renal Insufficiency |
5
6.7%
|
| Receiving any form of dialysis |
0
0%
|
| Chronic Renal Failure |
0
0%
|
| Renal Microemboli |
0
0%
|
| Chronic urinary tract infections |
1
1.3%
|
| Incontinence bladder problems |
3
4%
|
| Gastrointestinal bleeding |
2
2.7%
|
| Bowel ischemia |
0
0%
|
| Bowel obstruction |
1
1.3%
|
| Bowel fistulas |
0
0%
|
| Paralytic or adynamic ileus |
0
0%
|
| Impotence including erectile dysfunction |
8
10.7%
|
| Other |
42
56%
|
| Neurological History (Count of Participants) | |
| Reversible Ischemic Neurologic Disease |
0
0%
|
| Paraplegia |
0
0%
|
| Parasthesia |
1
1.3%
|
| Chronic Back Pain |
18
24%
|
| Chronic Headaches, Migraines |
3
4%
|
| Other |
20
26.7%
|
| Endocrine History (Count of Participants) | |
| Diabetes Type I |
0
0%
|
| Diabetes Type II |
22
29.3%
|
| Diabetic incompressible vessels |
0
0%
|
| Immunodeficiency |
2
2.7%
|
| Hyperthyroidism or Hypothyroidism |
8
10.7%
|
| Other |
5
6.7%
|
| Hematological History (Count of Participants) | |
| Hemorrhage |
0
0%
|
| Coagulopathy disorder |
0
0%
|
| Anemia |
5
6.7%
|
| Platelet Disorder |
0
0%
|
| Other |
5
6.7%
|
| Psychosocial History (Count of Participants) | |
| Depression |
7
9.3%
|
| Prior substance abuse |
1
1.3%
|
| Alcohol |
3
4%
|
| Illicit drugs |
0
0%
|
| Other |
4
5.3%
|
| Miscellaneous Medical History (Count of Participants) | |
| Connective Tissue Disorder |
0
0%
|
| Allergy, Intolerance to PTFE, polymers, FEP, nitinol |
0
0%
|
| Hypersensitivity to anticoagulation, contrast |
0
0%
|
| Cancer |
14
18.7%
|
| Liver Disease |
5
6.7%
|
| Other significant medical, surgical history |
26
34.7%
|
| Juxtarenal angle (degrees) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [degrees] |
23.1
(18.7)
|
| Aortic diameter Inferior Renal -35mm (mm) [Mean (Standard Deviation) ] | |
| Minimum |
25.0
(2.3)
|
| Maximum |
26.6
(2.4)
|
| Average |
25.9
(2.3)
|
| Aortic diameter inferior renal (mm) [Mean (Standard Deviation) ] | |
| Minimum |
21.8
(2.5)
|
| Maximum |
23.2
(2.6)
|
| Average |
22.5
(2.5)
|
| Aortic diameter inferior renal +7mm (mm) [Mean (Standard Deviation) ] | |
| Minimum |
21.8
(2.3)
|
| Maximum |
23.0
(2.7)
|
| Average |
22.4
(2.4)
|
| Change from diameter at inferior renal artery to inferior renal artery diameter at +7mm (%) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [%] |
0.0
(7.2)
|
| Aortic diameter inferior renal +10mm (mm) [Mean (Standard Deviation) ] | |
| Minimum |
21.8
(2.5)
|
| Maximum |
23.4
(2.8)
|
| Average |
22.6
(2.5)
|
| Maximum Sac Diameter (Count of Participants) | |
| <40 mm |
4
5.3%
|
| ≥40, <50 mm |
23
30.7%
|
| ≥ 50, <60 mm |
40
53.3%
|
| ≥ 60 mm |
8
10.7%
|
| Native Bifurcation (mm) [Mean (Standard Deviation) ] | |
| Minimum |
20.1
(5.1)
|
| Maximum |
26.2
(6.7)
|
| Transverse dimension of adjacent normal aortic segment (mm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mm] |
22.7
(4.1)
|
| Neck Length (mm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mm] |
27.9
(13.7)
|
| Distance from the most distal renal artery to most superior left internal iliac artery (mm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mm] |
182.5
(24.7)
|
| Distance from the most distal renal artery to most superior right internal iliac artery (mm) 75 181. (mm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mm] |
181.2
(21.0)
|
| Inferior Renal to Aortic Bifurcation (mm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mm] |
110.9
(13.1)
|
| Right Distal Iliac Diameter (mm) [Mean (Standard Deviation) ] | |
| Minimum |
15.8
(3.8)
|
| Maximum |
17.1
(4.0)
|
| Average |
16.5
(3.9)
|
| Right external iliac diameter (mm) [Mean (Standard Deviation) ] | |
| Minimum |
7.6
(1.6)
|
| Maximum |
8.7
(1.6)
|
| Average |
8.1
(1.5)
|
| Left distal iliac diameter (mm) [Mean (Standard Deviation) ] | |
| Minimum |
15.1
(3.0)
|
| Maximum |
16.4
(3.3)
|
| Average |
15.8
(3.1)
|
| Left external iliac diameter (mm) [Mean (Standard Deviation) ] | |
| Minimum |
7.6
(1.9)
|
| Maximum |
8.7
(1.6)
|
| Average |
8.2
(1.7)
|
| Left distal iliac landing zone (mm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mm] |
49.1
(18.7)
|
| Right distal iliac landing zone (mm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mm] |
50.1
(20.7)
|
| SIR Calcification Grade (Count of Participants) | |
| Calcification 0% of circumference |
14
18.7%
|
| Calcification <25% of circumference |
49
65.3%
|
| Calcification 25-50% of circumference |
11
14.7%
|
| Calcification >50% of circumference |
1
1.3%
|
| SIR Thrombus Grade (Count of Participants) | |
| Thrombus 0% of circumference |
27
36%
|
| Thrombus <25% of circumference |
16
21.3%
|
| Thrombus 25-50% of circumference |
18
24%
|
| Thrombus >50% of circumference |
14
18.7%
|
Outcome Measures
| Title | Number of Subjects With Treatment Success |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 61 |
| Count of Participants [Participants] |
58
77.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ovation Alto Abdominal Stent Graft System |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | One-sided Clopper-Pearson 95% confidence interval | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Clopper-Pearson |
| Estimated Value | 80 | |
| Confidence Interval |
(1-Sided) 95% to 95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | One-sided Clopper-Pearson 95% confidence interval | |
| Title | Event Rates for Endoleaks |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| 1 month : Type I |
0
|
| 1 month : Type Ia |
1
|
| 1 month : Type Ib |
0
|
| 1 month : Type II |
34
|
| 1 month : Type III |
0
|
| 1 month : Type IIIA |
0
|
| 1 month : Type IIIB |
0
|
| 1 month : Type IV |
0
|
| 1 month : Unknown |
3
|
| 6 month : Type I |
0
|
| 6 month : Type Ia |
0
|
| 6 month : Type Ib |
0
|
| 6 month : Type II |
30
|
| 6 month : Type III |
0
|
| 6 month : Type IIIA |
0
|
| 6 month : Type IIIB |
0
|
| 6 month : Type IV |
0
|
| 6 month : Unknown |
0
|
| 1 year : Type I |
0
|
| 1 year : Type Ia |
0
|
| 1 year : Type Ib |
0
|
| 1 year : Type II |
25
|
| 1 year : Type III |
0
|
| 1 year : Type IIIA |
0
|
| 1 year : Type IIIB |
0
|
| 1 year : Type IV |
0
|
| 1 year : Unknown |
2
|
| Title | Number of Participants With Stent Graft Migration > 10mm |
|---|---|
| Description | any change of stent graft migration (movement) greater than 10mm |
| Time Frame | 6 months, 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on all data available; imaging not available for all subjects to determine migration. |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 71 |
| 6 Months |
0
0%
|
| 1 Year |
0
0%
|
| Title | Number of Participants With AAA Enlargement > 5mm |
|---|---|
| Description | Change in aneurysm diameter greater than 5mm |
| Time Frame | 6 months, 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects lost to follow-up withdrawn, death, or imaging not available. |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 72 |
| 6 months |
0
0%
|
| 12 months |
1
1.3%
|
| Title | Number of Participants With AAA Rupture |
|---|---|
| Description | A tear in the abdominal aorta that can result in serious internal bleeding. |
| Time Frame | 30 day, Day 31-365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| 1 month |
0
0%
|
| Day 31-365 |
0
0%
|
| Title | Number of Participants With Conversion to Open Repair |
|---|---|
| Description | conversion to open abdominal surgery to repair AAA |
| Time Frame | 30 day, Day 31-365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| 30 day |
0
0%
|
| Day 31 to 365 |
1
1.3%
|
| Title | Number of Secondary Interventions |
|---|---|
| Description | Intervention occurring after index procedure and having to do with device or AAA. |
| Time Frame | 30 days, Day 31-365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| 1 month |
0
0%
|
| Day 31 - 365 |
2
2.7%
|
| Title | Number of Participants With AAA-related Mortality |
|---|---|
| Description | death caused by or related to AAA |
| Time Frame | 1 month, Day 31-365 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| 30 days |
0
0%
|
| Day 31 to 365 |
0
0%
|
| Title | Device-related Adverse Events (AEs) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| 30 days : Infections and Infestations |
0
0%
|
| 30 days : Product Issues |
1
1.3%
|
| Day 31-365 : Infections and Infestations |
1
1.3%
|
| Day 31-365 : Product Issues |
0
0%
|
| Title | Major Adverse Events |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| Deaths : 30 days |
0
0%
|
| Deaths : 31-365 days |
3
4%
|
| Bowel Ischemia : 30 days |
3
4%
|
| Bowel Ischemia : 31-365 days |
0
0%
|
| Myocardial Infarction : 30 days |
0
0%
|
| Myocardial Infarction : 31-365 days |
1
1.3%
|
| Paralysis : 30 days |
0
0%
|
| Paralysis : 31-365 days |
0
0%
|
| Renal Failure : 30 days |
0
0%
|
| Renal Failure : 31-365 days |
0
0%
|
| Respiratory Failure : 30 days |
0
0%
|
| Respiratory Failure : 31-365 days |
0
0%
|
| Stroke : 30 days |
0
0%
|
| Stroke : 31-365 days |
0
0%
|
| Procedural Blood Loss >1000cc : 30 days |
1
1.3%
|
| Procedural Blood Loss >1000cc : 31-365 days |
0
0%
|
| Title | Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Imaging not available for every subject at every timepoint |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 74 |
| 1 Month |
0
0%
|
| 6 Months |
0
0%
|
| 1 Year |
0
0%
|
| Title | Number of Participants With Stent Fracture |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects lost to follow-up withdrawn, death, or imaging not available. |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 70 |
| 1 month |
0
0%
|
| 6 months |
0
0%
|
| 12 months |
0
0%
|
| Title | Adverse Events (Serious and Non-serious) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| 30 days : Blood and lymphatic System Disorder |
0
0%
|
| 30 days : Cardiac Disorder |
0
0%
|
| 30 days : Ear and Labyrinth Disorders |
0
0%
|
| 30 days : Gastrointestinal Disorders |
4
5.3%
|
| 30 days : General Disorders and Administration Site Conditions |
13
17.3%
|
| 30 days : Hepatobiliary Disorders |
0
0%
|
| 30 days : Immune System Disorder |
2
2.7%
|
| 30 days : Infections and Infestations |
5
6.7%
|
| 30 days : Injury, Poisoning and Procedural Complications |
5
6.7%
|
| 30 days : Musculoskeletal and Connective Tissue Disorders |
1
1.3%
|
| 30 days : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps) |
0
0%
|
| 30 days : Nervous System Disorders |
1
1.3%
|
| 30 days : Other |
2
2.7%
|
| 30 days : Product Issues |
1
1.3%
|
| 30 days : Psychiatric Disorders |
1
1.3%
|
| 30 days : Renal and Urinary Disorders |
4
5.3%
|
| 30 days : Respiratory, Thoracic and Mediastinal Disorders |
2
2.7%
|
| 30 days : Vascular Disorders |
7
9.3%
|
| Day 31-365 : Blood and lymphatic System Disorder |
2
2.7%
|
| Day 31-365 : Cardiac Disorder |
11
14.7%
|
| Day 31-365 : Ear and Labyrinth Disorders |
1
1.3%
|
| Day 31-365 : Gastrointestinal Disorders |
3
4%
|
| Day 31-365 : General Disorders and Administration Site Conditions |
15
20%
|
| Day 31-365 : Hepatobiliary Disorders |
2
2.7%
|
| Day 31-365 : Immune System Disorder |
1
1.3%
|
| Day 31-365 : Infections and Infestations |
2
2.7%
|
| Day 31-365 : Injury, Poisoning and Procedural Complications |
2
2.7%
|
| Day 31-365 : Musculoskeletal and Connective Tissue Disorders |
7
9.3%
|
| Day 31-365 : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps) |
4
5.3%
|
| Day 31-365 : Nervous System Disorders |
3
4%
|
| Day 31-365 : Other |
2
2.7%
|
| Day 31-365 : Product Issues |
0
0%
|
| Day 31-365 : Psychiatric Disorders |
0
0%
|
| Day 31-365 : Renal and Urinary Disorders |
4
5.3%
|
| Day 31-365 : Respiratory, Thoracic and Mediastinal Disorders |
3
4%
|
| Day 31-365 : Vascular Disorders |
9
12%
|
| Title | Procedure-related Adverse Event |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| 30 days : Gastrointestinal Disorders |
2
2.7%
|
| 30 days : General Disorders and Administration Site Conditions |
0
0%
|
| 30 days : Injury Poisoning and Procedural Complications |
3
4%
|
| 30 days : Product Issues |
1
1.3%
|
| 30 days : Vascular Disorders |
0
0%
|
| Day 31-365 : Gastrointestinal Disorders |
0
0%
|
| Day 31-365 : General Disorders and Administration Site Conditions |
2
2.7%
|
| Day 31-365 : Injury Poisoning and Procedural Complications |
0
0%
|
| Day 31-365 : Product Issues |
0
0%
|
| Day 31-365 : Vascular Disorders |
1
1.3%
|
| Title | Serious Adverse Event |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 75 |
| 30 days : Cardiac disorders |
0
0%
|
| 30 days : Gastrointestinal Disorders |
2
2.7%
|
| 30 days : Infections and Infestations |
0
0%
|
| 30 days : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps) |
0
0%
|
| 30 days : Nervous System Disorders |
0
0%
|
| 30 days : Product Issues |
1
1.3%
|
| 30 days : Vascular Disorders |
0
0%
|
| 30 days : Injury, Poisoning and Procedural Complications |
2
2.7%
|
| Day 31-365 : Cardiac disorders |
2
2.7%
|
| Day 31-365 : Gastrointestinal Disorders |
0
0%
|
| Day 31-365 : Infections and Infestations |
1
1.3%
|
| Day 31-365 : Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps) |
1
1.3%
|
| Day 31-365 : Nervous System Disorders |
1
1.3%
|
| Day 31-365 : Product Issues |
0
0%
|
| Day 31-365 : Vascular Disorders |
1
1.3%
|
| Day 31-365 : Injury, Poisoning and Procedural Complications |
0
0%
|
Adverse Events
| Time Frame | AEs were collected over 1 year. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Ovation Alto Abdominal Stent Graft System | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Ovation Alto Abdominal Stent Graft System | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/75 (4%) | |
Serious Adverse Events |
||
| Ovation Alto Abdominal Stent Graft System | ||
| Affected / at Risk (%) | # Events | |
| Total | 11/75 (14.7%) | |
| Cardiac disorders | ||
| Myocardial Infarction | 1/75 (1.3%) | |
| Unknown Cause of Death | 1/75 (1.3%) | |
| Gastrointestinal disorders | ||
| Bowel Ischemia | 3/75 (4%) | |
| Infections and infestations | ||
| Device Infection | 1/75 (1.3%) | |
| Injury, poisoning and procedural complications | ||
| Procedural Blood Loss | 1/75 (1.3%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Lung Cancer | 1/75 (1.3%) | |
| Nervous system disorders | ||
| Other | 1/75 (1.3%) | |
| Product Issues | ||
| Endoleak Ia | 1/75 (1.3%) | |
| Vascular disorders | ||
| Aneurysm Expansion | 1/75 (1.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Ovation Alto Abdominal Stent Graft System | ||
| Affected / at Risk (%) | # Events | |
| Total | 54/75 (72%) | |
| Blood and lymphatic system disorders | ||
| anemia | 2/75 (2.7%) | |
| Cardiac disorders | ||
| Angina | 1/75 (1.3%) | |
| Arrhythmia | 3/75 (4%) | |
| Congestive Heart Failure | 3/75 (4%) | |
| Edema | 1/75 (1.3%) | |
| Syncope (Cardiac) | 1/75 (1.3%) | |
| Valve Disorder | 1/75 (1.3%) | |
| Hypovolemia | 1/75 (1.3%) | |
| Left ventricular outflow tract obstruction | 1/75 (1.3%) | |
| Ear and labyrinth disorders | ||
| cataract surgery | 1/75 (1.3%) | |
| Gastrointestinal disorders | ||
| Adynamic Ileus | 1/75 (1.3%) | |
| Routine CT scan done for follow up of AAA stent graft repair | 1/75 (1.3%) | |
| diarrhea | 2/75 (2.7%) | |
| constipation | 1/75 (1.3%) | |
| Esophageal Stricture | 1/75 (1.3%) | |
| General disorders | ||
| Anticoagulant Related Bleeding | 1/75 (1.3%) | |
| Endoleak IA | 1/75 (1.3%) | |
| Endoleak II | 27/75 (36%) | |
| Medication Reaction | 1/75 (1.3%) | |
| Numbness | 1/75 (1.3%) | |
| Acute exacerbation of chronic lower back pain | 1/75 (1.3%) | |
| head laceration (due to fall) | 1/75 (1.3%) | |
| right foot pain | 1/75 (1.3%) | |
| Sleeplessness due to PTSD | 1/75 (1.3%) | |
| Hypokalemia | 1/75 (1.3%) | |
| Endoleak (unknown) | 1/75 (1.3%) | |
| Hepatobiliary disorders | ||
| Choledocholithiasis | 1/75 (1.3%) | |
| cholecystectomy | 1/75 (1.3%) | |
| Immune system disorders | ||
| Medication Reaction | 1/75 (1.3%) | |
| Gout | 1/75 (1.3%) | |
| Polymyalgia Rheumatica | 1/75 (1.3%) | |
| Infections and infestations | ||
| COPD | 1/75 (1.3%) | |
| Pneumonia | 1/75 (1.3%) | |
| UTI | 3/75 (4%) | |
| MRSA and Enterococcus of the right 4th toe | 1/75 (1.3%) | |
| left plank pain | 1/75 (1.3%) | |
| Injury, poisoning and procedural complications | ||
| Hematuria | 1/75 (1.3%) | |
| Sub-Dermal Hematoma | 1/75 (1.3%) | |
| degenerative changes to the body wall | 1/75 (1.3%) | |
| decreased pulse in right foot | 1/75 (1.3%) | |
| pain in the toes of the right foot | 1/75 (1.3%) | |
| Nausea | 1/75 (1.3%) | |
| Post Implant Syndrome | 1/75 (1.3%) | |
| air leak status post left lobectomy | 1/75 (1.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Bone Fracture | 1/75 (1.3%) | |
| Rhabdomyolysis | 1/75 (1.3%) | |
| Pain in right foot with toe discoloration | 1/75 (1.3%) | |
| Severe osteoarthritis right hip | 1/75 (1.3%) | |
| left leg pain | 1/75 (1.3%) | |
| Sciatica pain | 1/75 (1.3%) | |
| Right forearm bruising | 1/75 (1.3%) | |
| swelling of right leg below the knee | 1/75 (1.3%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Lung Cancer | 1/75 (1.3%) | |
| Left breast cancer | 1/75 (1.3%) | |
| colon cancer | 1/75 (1.3%) | |
| Nervous system disorders | ||
| Syncope (cardiac) | 1/75 (1.3%) | |
| TIA | 1/75 (1.3%) | |
| Ulnar Mononeuropathy | 1/75 (1.3%) | |
| Altered mental status | 1/75 (1.3%) | |
| Psychiatric disorders | ||
| Encephalopathy | 1/75 (1.3%) | |
| Renal and urinary disorders | ||
| Acute Renal Failure | 2/75 (2.7%) | |
| Blood in urine | 1/75 (1.3%) | |
| Urinary Retention | 1/75 (1.3%) | |
| Hematuria | 1/75 (1.3%) | |
| left testicular infarction | 1/75 (1.3%) | |
| AKI on CKD | 1/75 (1.3%) | |
| Prostatitis | 1/75 (1.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Atelectasis | 1/75 (1.3%) | |
| Shortness of Breath | 1/75 (1.3%) | |
| hypoxemia | 1/75 (1.3%) | |
| Pneumonia | 1/75 (1.3%) | |
| Respiratory Failure | 1/75 (1.3%) | |
| Restrictive lung disease | 1/75 (1.3%) | |
| Sleep apnea | 1/75 (1.3%) | |
| Acute Hypoxic Respiratory Failure | 1/75 (1.3%) | |
| benign lung nodule | 1/75 (1.3%) | |
| Vascular disorders | ||
| Claudication | 2/75 (2.7%) | |
| Deep Vein Thrombosis | 1/75 (1.3%) | |
| Embolism | 1/75 (1.3%) | |
| Hypertension | 1/75 (1.3%) | |
| Hypotension | 1/75 (1.3%) | |
| plaque obstructing true lumen (iliofemoral endarterectomy) | 1/75 (1.3%) | |
| Proglide failure during surgical closure of left groin incision | 1/75 (1.3%) | |
| Bilateral Popliteal Artery Aneurysms | 1/75 (1.3%) | |
| Thoracic Aortic Aneurysm | 1/75 (1.3%) | |
| carotid stenosis | 1/75 (1.3%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Manager, Clinical Affairs |
|---|---|
| Organization | Endologix, LLC |
| Phone | 864-270-8524 |
| nsmith@endologix.com |
Responsible Party:
Endologix
ClinicalTrials.gov Identifier:
NCT02949297
Other Study ID Numbers:
- 771-0013
First Posted:
Oct 31, 2016
Last Update Posted:
Dec 22, 2021
Last Verified:
Nov 1, 2021