Trial Outcomes & Findings for Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System (NCT NCT01491945)
NCT ID: NCT01491945
Last Updated: 2021-10-15
Results Overview
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
30 Days
Results posted on
2021-10-15
Participant Flow
Participant milestones
| Measure |
Ventana Fenestrated Stent Graft System
Objective is to study the safety and effectiveness of the Endologix Fenestrated Stent Graft System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms. Subjects were treated with the Ventana Fenestrated system in this arm and The Ventana Fenestrated Stent Graft System consisted of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts.
|
|---|---|
|
Overall Study
STARTED
|
76
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
Ventana Fenestrated Stent Graft System
Objective is to study the safety and effectiveness of the Endologix Fenestrated Stent Graft System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms. Subjects were treated with the Ventana Fenestrated system in this arm and The Ventana Fenestrated Stent Graft System consisted of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts.
|
|---|---|
|
Overall Study
Death
|
30
|
|
Overall Study
Withdrwan/LTF
|
16
|
|
Overall Study
Conversion
|
4
|
|
Overall Study
Missed Visit
|
1
|
Baseline Characteristics
Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
Baseline characteristics by cohort
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Age, Continuous
|
74.6 Years
STANDARD_DEVIATION 8.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
76 Participants
n=93 Participants
|
|
Serum Creatinine
|
1.1 mg/dL
STANDARD_DEVIATION 0.3 • n=93 Participants
|
|
ASA Class
ASA Class 1
|
1 Participants
n=93 Participants
|
|
ASA Class
ASA Class 2
|
27 Participants
n=93 Participants
|
|
ASA Class
ASA Class 3
|
38 Participants
n=93 Participants
|
|
ASA Class
ASA Class 4
|
10 Participants
n=93 Participants
|
|
estimated Glomerular Filtration Rate (eGFR)
|
77.9 mL/min/1.73m^2
STANDARD_DEVIATION 30.1 • n=93 Participants
|
|
Ankle Brachial Index
ABI Left
|
1.0 Ratio (percentage)
STANDARD_DEVIATION 0.2 • n=93 Participants
|
|
Ankle Brachial Index
ABI RIght
|
1.0 Ratio (percentage)
STANDARD_DEVIATION 0.2 • n=93 Participants
|
|
Aneurysm Shape
Fusiform
|
69 Participants
n=93 Participants
|
|
Aneurysm Shape
Saccular
|
7 Participants
n=93 Participants
|
|
Aneurysm Sac Diameter
|
5.8 centimeter
STANDARD_DEVIATION 0.8 • n=93 Participants
|
|
Aneurysm Diameter (mm)
<45 mm
|
1 Participants
n=93 Participants
|
|
Aneurysm Diameter (mm)
>=45-54 mm
|
28 Participants
n=93 Participants
|
|
Aneurysm Diameter (mm)
>=55-64 mm
|
33 Participants
n=93 Participants
|
|
Aneurysm Diameter (mm)
>=65-74 mm
|
12 Participants
n=93 Participants
|
|
Aneurysm Diameter (mm)
>=75-84 mm
|
1 Participants
n=93 Participants
|
|
Aneurysm Diameter (mm)
>=85 mm
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 30 DaysMajor Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Safety- Number of Major Adverse Events at 30 Days
All Cause Death
|
2 Events
|
|
Safety- Number of Major Adverse Events at 30 Days
Bowel Ischemia
|
3 Events
|
|
Safety- Number of Major Adverse Events at 30 Days
Myocardial Infarction
|
2 Events
|
|
Safety- Number of Major Adverse Events at 30 Days
Paraplegia
|
1 Events
|
|
Safety- Number of Major Adverse Events at 30 Days
Procedural Blood Loss
|
5 Events
|
|
Safety- Number of Major Adverse Events at 30 Days
Renal Failure 1 - Temporary/Permanent Hemodialysis
|
4 Events
|
|
Safety- Number of Major Adverse Events at 30 Days
Renal Failure 2 - Serum Creatine >0.5mg/dL
|
3 Events
|
|
Safety- Number of Major Adverse Events at 30 Days
Respiratory Failure 1 - Pneumonia
|
1 Events
|
|
Safety- Number of Major Adverse Events at 30 Days
Respiratory Failure 2 - Ventilator >24hr
|
2 Events
|
|
Safety- Number of Major Adverse Events at 30 Days
Stroke
|
0 Events
|
PRIMARY outcome
Timeframe: 1 Year1. Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. 2. Procedural Technical Success is defined as a subject with successful implant. 3. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 4. Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). 5. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Effectiveness
Aneurysm Rupture
|
0 Participants
|
|
Effectiveness
Conversion to Open Repair
|
1 Participants
|
|
Effectiveness
Secondary Interventions
|
18 Participants
|
|
Effectiveness
Aneurysm Enlargement
|
5 Participants
|
|
Effectiveness
Clinically Significant Migration
|
0 Participants
|
|
Effectiveness
Type IA Endoleak
|
0 Participants
|
|
Effectiveness
Type IB Endoleak
|
1 Participants
|
|
Effectiveness
Type IIIA Endoleak
|
2 Participants
|
|
Effectiveness
Type IIIB Endoleak
|
2 Participants
|
|
Effectiveness
Procedural Technical Success
|
74 Participants
|
SECONDARY outcome
Timeframe: >30 Days to 5 YearsPopulation: All available data has been reported.
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=74 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
All Cause Death
|
28 Number of events
|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Bowel Ischemia
|
2 Number of events
|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Myocardial Infarction
|
3 Number of events
|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Paraplegia
|
0 Number of events
|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Procedural Blood Loss
|
0 Number of events
|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Renal Failure 1 - Temporary/Permanent Hemodialysis
|
10 Number of events
|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Renal Failure 2 - Serum Creatinine >0.5mg/dL rise
|
2 Number of events
|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Respiratory Failure 1 - Pneumonia
|
9 Number of events
|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Respiratory Failure 2 - Ventilator >24 Hours
|
3 Number of events
|
|
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Stroke
|
6 Number of events
|
SECONDARY outcome
Timeframe: Discharge to 5 YearsRenal Dysfunction is calculated at greater than 30% reduction starting at baseline
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Renal Dysfunction
1-Month Follow-up
|
9 Participants
|
|
Renal Dysfunction
6-Month Follow-up
|
11 Participants
|
|
Renal Dysfunction
1-Year Follow-up
|
22 Participants
|
|
Renal Dysfunction
2-Year Follow-up
|
16 Participants
|
|
Renal Dysfunction
3-Year Follow-up
|
11 Participants
|
|
Renal Dysfunction
4-Year Follow-up
|
11 Participants
|
|
Renal Dysfunction
5-Year Follow-up
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 Days to 5 YearsPopulation: All available data based on different timepoints has been reported.
Endoleaks- Type IA, Type IB, Type II, Type IIIA, Type IIIB, Type IV, and Unknown Type Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=69 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Endoleaks
Type IA- 1 month
|
0 Participants
|
|
Endoleaks
Type IB- 1 Month
|
0 Participants
|
|
Endoleaks
Type II - 1 month
|
11 Participants
|
|
Endoleaks
Type IIIA- 1 month
|
0 Participants
|
|
Endoleaks
Type IIIB - 1 month
|
0 Participants
|
|
Endoleaks
Type IV - 1 month
|
0 Participants
|
|
Endoleaks
Unknown Type - 1 month
|
6 Participants
|
|
Endoleaks
Type IA - 6 month
|
0 Participants
|
|
Endoleaks
Type IB- 6 Month
|
0 Participants
|
|
Endoleaks
Type II- 6 Month
|
9 Participants
|
|
Endoleaks
Type IIIA- 6 Month
|
0 Participants
|
|
Endoleaks
Type IIIB- 6 Month
|
0 Participants
|
|
Endoleaks
Type IV- 6 Month
|
0 Participants
|
|
Endoleaks
Unknown Type- 6 Month
|
5 Participants
|
|
Endoleaks
Type IA- 1 Year
|
0 Participants
|
|
Endoleaks
Type IB -1 Year
|
1 Participants
|
|
Endoleaks
Type II -1 Year
|
6 Participants
|
|
Endoleaks
Type IIIA- 1 Year
|
2 Participants
|
|
Endoleaks
Type IIIB- 1 Year
|
2 Participants
|
|
Endoleaks
Type IV - 1 Year
|
0 Participants
|
|
Endoleaks
Unknown Type- 1 Year
|
4 Participants
|
|
Endoleaks
Type IA- 2 year
|
0 Participants
|
|
Endoleaks
Type IB- 2 Year
|
0 Participants
|
|
Endoleaks
Type II- 2 Year
|
6 Participants
|
|
Endoleaks
Type IIIA- 2 Year
|
2 Participants
|
|
Endoleaks
Type IIIB- 2 Year
|
3 Participants
|
|
Endoleaks
Type IV- 2 Year
|
0 Participants
|
|
Endoleaks
Unknown Type- 2 Year
|
4 Participants
|
|
Endoleaks
Type IA- 3 Year
|
0 Participants
|
|
Endoleaks
Type IB- 3 Year
|
0 Participants
|
|
Endoleaks
Type II- 3 Year
|
5 Participants
|
|
Endoleaks
Type IIIA- 3 Year
|
0 Participants
|
|
Endoleaks
Type IIIB- 3 Year
|
1 Participants
|
|
Endoleaks
Type IV- 3 Year
|
0 Participants
|
|
Endoleaks
Unknown Type- 3 Year
|
2 Participants
|
|
Endoleaks
Type IA- 4 Year
|
0 Participants
|
|
Endoleaks
Type IB- 4 Year
|
0 Participants
|
|
Endoleaks
Type II- 4 Year
|
4 Participants
|
|
Endoleaks
Type IIIA- 4 Year
|
0 Participants
|
|
Endoleaks
Type IIIB- 4 Year
|
2 Participants
|
|
Endoleaks
Type IV- 4 Year
|
0 Participants
|
|
Endoleaks
Unknown Type- 4 Year
|
3 Participants
|
|
Endoleaks
Type IA- 5 Year
|
0 Participants
|
|
Endoleaks
Type IB- 5 Year
|
0 Participants
|
|
Endoleaks
Type II- 5 Year
|
1 Participants
|
|
Endoleaks
Type IIIA- 5 Year
|
0 Participants
|
|
Endoleaks
Type IIIB- 5 Year
|
1 Participants
|
|
Endoleaks
Type IV- 5 Year
|
0 Participants
|
|
Endoleaks
Unknown Type- 5 Year
|
2 Participants
|
SECONDARY outcome
Timeframe: At the time of the procedureClinical Utility Outcomes consist of: fluoroscopy time, Bifurcated device placement time, Renal Artery Cannulation time, F-EVAR time and total procedure time.
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Clinical Utility Outcomes
Fluoroscopy Time
|
58 Mins
Standard Deviation 33
|
|
Clinical Utility Outcomes
Bifurcated Device Placement Time
|
56 Mins
Standard Deviation 24
|
|
Clinical Utility Outcomes
Renal Artery Cannulation Time
|
35 Mins
Standard Deviation 45
|
|
Clinical Utility Outcomes
F-EVAR Time
|
68 Mins
Standard Deviation 32
|
|
Clinical Utility Outcomes
Total Procedure Time
|
205 Mins
Standard Deviation 84
|
SECONDARY outcome
Timeframe: In-HospitalNumber of days spent in the intensive care unit (ICU)
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Time in ICU
|
3 Days
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Hospital Discharge (Post-Procedure)Number of days from the index procedure to discharge from the hospital.
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Time to Hospital Discharge
|
4 Days
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 30 Days to 5 YearsPopulation: All available data at various timepoints have been reported
Device patency- Ventana \& Bifurcated Occlusion, Left Renal Artery Occlusion, and Right Renal Artery Occlusion
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=69 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Device Patency
Ventana & Bifurcated Occlusion - 1 Month
|
0 Participants
|
|
Device Patency
Left Renal Artery Occlusion - 1 month
|
2 Participants
|
|
Device Patency
Right Renal Artery Occlusion - 1month
|
3 Participants
|
|
Device Patency
Ventana & Bifurcated Occlusion- 6 Month
|
0 Participants
|
|
Device Patency
Left Renal Artery Occlusion- 6 Month
|
2 Participants
|
|
Device Patency
Right Renal Artery Occlusion- 6 Month
|
2 Participants
|
|
Device Patency
Ventana & Bifurcated Occlusion- 1 Year
|
0 Participants
|
|
Device Patency
Left Renal Artery Occlusion- 1 Year
|
2 Participants
|
|
Device Patency
Right Renal Artery Occlusion- 1 Year
|
0 Participants
|
|
Device Patency
Ventana & Bifurcated Occlusion- 2 Year
|
0 Participants
|
|
Device Patency
Left Renal Artery Occlusion- 2 Year
|
1 Participants
|
|
Device Patency
Right Renal Artery Occlusion- 2 Year
|
1 Participants
|
|
Device Patency
Ventana & Bifurcated Occlusion- 3 Year
|
0 Participants
|
|
Device Patency
Left Renal Artery Occlusion- 3 Year
|
0 Participants
|
|
Device Patency
Right Renal Artery Occlusion- 3 Year
|
0 Participants
|
|
Device Patency
Ventana & Bifurcated Occlusion - 4 Year
|
0 Participants
|
|
Device Patency
Left Renal Artery Occlusion- 4 Year
|
0 Participants
|
|
Device Patency
Right Renal Artery Occlusion- 4 Year
|
0 Participants
|
|
Device Patency
Ventana & Bifurcated Occlusion- 5 Year
|
0 Participants
|
|
Device Patency
Left Renal Artery Occlusion- 5 Year
|
0 Participants
|
|
Device Patency
Right Renal Artery Occlusion- 5 Year
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 Days to 5 YearsPopulation: All available data at various timepoints has been reported
Device Integrity- Device Migration, Ventana Stent Fracture, Left Renal Stent Fracture, Right Renal Stent Fracture, and Stent Kinking/ Compression
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=73 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Device Integrity
Device Migration- 6 Month
|
0 Participants
|
|
Device Integrity
Device Migration- 1 year
|
0 Participants
|
|
Device Integrity
Device Migration- 2 year
|
0 Participants
|
|
Device Integrity
Device Migration- 3 year
|
0 Participants
|
|
Device Integrity
Device Migration- 4 year
|
0 Participants
|
|
Device Integrity
Device Migration- 5 year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture- 1 Month
|
1 Participants
|
|
Device Integrity
Left Renal Stent Fracture- 1 Month
|
1 Participants
|
|
Device Integrity
Right Renal Stent Fracture- 1 Month
|
0 Participants
|
|
Device Integrity
Stent Kinking/ Compression- 1 Month
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture- 6 Month
|
3 Participants
|
|
Device Integrity
Left Renal Stent Fracture- 6 Month
|
2 Participants
|
|
Device Integrity
Right Renal Stent Fracture- 6 Month
|
0 Participants
|
|
Device Integrity
Stent Kinking/ Compression- 6 Month
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture- 1 Year
|
7 Participants
|
|
Device Integrity
Left Renal Stent Fracture- 1 Year
|
7 Participants
|
|
Device Integrity
Right Renal Stent Fracture- 1 Year
|
1 Participants
|
|
Device Integrity
Stent Kinking/ Compression- 1 Year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture- 2 Year
|
12 Participants
|
|
Device Integrity
Left Renal Stent Fracture- 2 Year
|
8 Participants
|
|
Device Integrity
Right Renal Stent Fracture- 2 Year
|
2 Participants
|
|
Device Integrity
Stent Kinking/ Compression- 2 Year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture- 3 Year
|
10 Participants
|
|
Device Integrity
Left Renal Stent Fracture- 3 Year
|
5 Participants
|
|
Device Integrity
Right Renal Stent Fracture- 3 Year
|
3 Participants
|
|
Device Integrity
Stent Kinking/ Compression- 3 Year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture- 4 Year
|
13 Participants
|
|
Device Integrity
Left Renal Stent Fracture- 4 Year
|
3 Participants
|
|
Device Integrity
Right Renal Stent Fracture- 4 Year
|
4 Participants
|
|
Device Integrity
Stent Kinking/ Compression- 4 Year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture- 5 Year
|
11 Participants
|
|
Device Integrity
Left Renal Stent Fracture- 5 Year
|
3 Participants
|
|
Device Integrity
Right Renal Stent Fracture- 5 Year
|
2 Participants
|
|
Device Integrity
Stent Kinking/ Compression- 5 Year
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 Days to 5 YearsPopulation: All available data has been reported
Aneurysm Sac Morphology- Aneurysm Shape, Aneurysm Enlargement
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Aneurysm Sac Morphology
Aneurysm Shape- Saccular
|
7 Participants
|
|
Aneurysm Sac Morphology
Aneurysm Enlargement - 6 months
|
1 Participants
|
|
Aneurysm Sac Morphology
Aneurysm Enlargement - 1 year
|
4 Participants
|
|
Aneurysm Sac Morphology
Aneurysm Shape- Fusiform
|
69 Participants
|
|
Aneurysm Sac Morphology
Aneurysm Enlargement - 2 year
|
8 Participants
|
|
Aneurysm Sac Morphology
Aneurysm Enlargement - 3 year
|
8 Participants
|
|
Aneurysm Sac Morphology
Aneurysm Enlargement - 4 year
|
6 Participants
|
|
Aneurysm Sac Morphology
Aneurysm Enlargement - 5 year
|
6 Participants
|
SECONDARY outcome
Timeframe: 30 Days to 5 YearsPopulation: All available data has been reported
Aneurysm Sac diameter changes
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Aneurysm Sac Diameter
Aneurysm Sac Diameter Changes - Screening / Baseline
|
58.4 mm
Standard Deviation 7.9
|
|
Aneurysm Sac Diameter
Aneurysm Sac Diameter Changes - 1 month
|
59.3 mm
Standard Deviation 7.6
|
|
Aneurysm Sac Diameter
Aneurysm Sac Diameter Changes - 6 month
|
57.6 mm
Standard Deviation 7.4
|
|
Aneurysm Sac Diameter
Aneurysm Sac Diameter Changes - 1 year
|
57.1 mm
Standard Deviation 8.3
|
|
Aneurysm Sac Diameter
Aneurysm Sac Diameter Changes - 2 year
|
56.7 mm
Standard Deviation 8.2
|
|
Aneurysm Sac Diameter
Aneurysm Sac Diameter Changes - 3 year
|
55.5 mm
Standard Deviation 8.8
|
|
Aneurysm Sac Diameter
Aneurysm Sac Diameter Changes - 4 year
|
56.9 mm
Standard Deviation 10.4
|
|
Aneurysm Sac Diameter
Aneurysm Sac Diameter Changes - 5 year
|
59.7 mm
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: At the time of the procedureClinical Utility Outcomes consists of: contrast volume and estimated blood loss.
Outcome measures
| Measure |
Ventana Fenestrated Stent Graft System
n=76 Participants
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Clinical Utility Outcomes
Contrast Volume
|
132 mL
Standard Deviation 64
|
|
Clinical Utility Outcomes
Blood loss
|
401 mL
Standard Deviation 513
|
Adverse Events
Ventana Fenestrated Stent Graft System
Serious events: 50 serious events
Other events: 71 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Ventana Fenestrated Stent Graft System
n=76 participants at risk
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.2%
7/76 • Number of events 7 • 5 years
|
|
Blood and lymphatic system disorders
Hemorrhagic anemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
AFib
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
3.9%
3/76 • Number of events 4 • 5 years
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Cardiac disorders
Cardiogenic shock
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiopulmonary arrest
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Cardiac disorders
Congestive heart failure
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Cardiac disorders
Coronary artery stenosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Heart block third degree
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Heart failure
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Intracardiac thrombus
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
ST segment elevation myocardial infarction
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Eye disorders
Ischemic optic neuropathy
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Acute pancreatitis
|
1.3%
1/76 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Bleeding gastrointestinal
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Bowel ischemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Bowel perforation
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Colitis ischemic
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diverticulosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Emesis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GI bleed
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Hemoperitoneum
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Ileus
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Left inguinal hernia
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
2.6%
2/76 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Necrotizing pancreatitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Pancreatic duct obstruction
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Peptic ulcer disease
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Peptic ulcer hemorrhage
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Perforated gastric ulcer
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Small bowel obstruction
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
UGI bleed
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
General disorders
Arterial stent occlusion
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Chest pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Death
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
General disorders
Device fracture
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Device insertion difficult
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Device issue
|
6.6%
5/76 • Number of events 5 • 5 years
|
|
General disorders
Device migration
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Edema
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Endoleak
|
5.3%
4/76 • Number of events 5 • 5 years
|
|
General disorders
Fatigue aggravated
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Multi organ failure
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
General disorders
Stent malfunction
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
General disorders
Stent strut fracture
|
5.3%
4/76 • Number of events 5 • 5 years
|
|
General disorders
Stent-graft angulation
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Stent-graft compression
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Stent-graft endoleak type IB
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Stent-graft endoleak type II
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
General disorders
Stent-graft endoleak type III
|
6.6%
5/76 • Number of events 5 • 5 years
|
|
General disorders
Stent-graft malfunction
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Stent-graft material failure
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Vascular stent thrombosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Weakness
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Hepatobiliary disorders
Acute cholecystitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Choledocholithiasis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Liver failure
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Acute diverticulitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Bacteremia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Chronic diverticulitis
|
1.3%
1/76 • Number of events 2 • 5 years
|
|
Infections and infestations
Groin abscess
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Incision site infection
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Infections and infestations
Mycoplasma pneumoniae pneumonia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Nosocomial pneumonia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Pneumonia
|
7.9%
6/76 • Number of events 9 • 5 years
|
|
Infections and infestations
Postoperative wound infection
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Sepsis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Chronic subdural hematoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Fractured femur (excl neck)
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Fractured hip
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Graft complication
|
2.6%
2/76 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Hematuria traumatic
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Injury, poisoning and procedural complications
Injury to iliac artery
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Intraoperative bleeding
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Leg fracture
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Mental status changes postoperative
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Procedural bleeding
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Renal hematoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Scalp laceration
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Splenic hematoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Investigations
Creatinine increased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
GFR decreased
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Gout flare
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Knee osteoarthritis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
weakness of Lower extremities
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis knee
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in hip
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain metastases
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid carcinoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urothelial carcinoma
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Nervous system disorders
Carotid artery stenosis
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Nervous system disorders
Cerebral infarction
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Cerebral vascular disturbance
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Hemorrhagic transformation due to acute stroke
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Intraventricular hemorrhage
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Progression of Alzheimer's disease
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Seizure
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord ischemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Stroke
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Nervous system disorders
Syncope
|
2.6%
2/76 • Number of events 3 • 5 years
|
|
Psychiatric disorders
Confusion
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Delirium
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Depression
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Major depression
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Acute kidney failure
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Renal and urinary disorders
Acute renal failure
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Renal and urinary disorders
Acute tubular necrosis
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Bilateral renal artery stenosis
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Renal and urinary disorders
Chronic renal failure
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Chronic renal failure worsened
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
End stage renal disease (ESRD)
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal artery dissection
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal artery occlusion
|
3.9%
3/76 • Number of events 4 • 5 years
|
|
Renal and urinary disorders
Renal artery stenosis
|
17.1%
13/76 • Number of events 15 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal parenchymal hemorrhage
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Unilateral renal artery stenosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxiation
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung mass
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Surgical and medical procedures
Surgical intervention
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Umbilical hernia repair
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Abdominal aneurysm, ruptured
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Abdominal aortic aneurysm enlargement
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Vascular disorders
Aneurysm enlargement
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Aortic aneurysm enlargement
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Aortic aneurysm rupture
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Arterial stenosis
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Vascular disorders
Arterial thrombosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Celiac artery occlusion
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Critical limb ischemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
DVT
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Femoral artery occlusion
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Femoral artery stenosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Hematoma
|
1.3%
1/76 • Number of events 2 • 5 years
|
|
Vascular disorders
Hypertension
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Vascular disorders
Hypotension
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Vascular disorders
Hypovolemic shock
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Arteriovenous Fistula placement
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Iliac artery dissection
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Iliac artery occlusion
|
2.6%
2/76 • Number of events 2 • 5 years
|
Other adverse events
| Measure |
Ventana Fenestrated Stent Graft System
n=76 participants at risk
Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.2%
10/76 • Number of events 13 • 5 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.6%
2/76 • Number of events 3 • 5 years
|
|
Blood and lymphatic system disorders
Splenic infarction
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Cardiac disorders
Acute heart failure
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Cardiac disorders
Atrial flutter
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Bradycardia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Congestive heart failure
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Premature atrial contraction
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Demand Ischemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Cardiac disorders
Tachycardia
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Cardiac disorders
Uremic pericarditis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Congenital, familial and genetic disorders
Hydrocele
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Congenital, familial and genetic disorders
Hydrocele, unspecified
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Eye disorders
Bilateral cataracts
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Eye disorders
Blepharospasm
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Eye disorders
Conjunctivitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Eye disorders
Eye pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
9.2%
7/76 • Number of events 7 • 5 years
|
|
Gastrointestinal disorders
Bowel incontinence
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Colitis
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Constipation aggravated
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Crohns disease aggravated
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
2/76 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Emesis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Ileus
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
Localized intraabdominal fluid collection
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
11.8%
9/76 • Number of events 9 • 5 years
|
|
Gastrointestinal disorders
Occlusion mesenteric artery
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
5/76 • Number of events 5 • 5 years
|
|
General disorders
Adverse drug reaction
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
General disorders
Chest pain
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
General disorders
Chest tightness
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Device migration
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Edema of lower extremities
|
2.6%
2/76 • Number of events 3 • 5 years
|
|
General disorders
Endoleak
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
General disorders
Energy decreased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Fever
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
General disorders
Leg edema
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Nodule
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Pain
|
2.6%
2/76 • Number of events 3 • 5 years
|
|
General disorders
Rigors
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Stent malapposition
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Stent occlusion
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
General disorders
Stent strut fracture
|
6.6%
5/76 • Number of events 5 • 5 years
|
|
General disorders
Stent-graft endoleak
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Stent-graft endoleak type IA
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Stent-graft endoleak type II
|
7.9%
6/76 • Number of events 6 • 5 years
|
|
General disorders
Stent-graft endoleak type III
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Weakness
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
General disorders
Weakness generalised
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Left Arm Swelling
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
General disorders
Ear Wax build-up
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Liver cholestasis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Acute cystitis with hematuria
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Acute bronchitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Bronchitis
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Infections and infestations
C.difficile colitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Candidemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Cellulitis
|
5.3%
4/76 • Number of events 5 • 5 years
|
|
Infections and infestations
Clostridium difficile infection
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Incision site cellulitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Intestinal infection due to clostridium difficile
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Left otitis externa
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Methicillin-resistant staphylococcal aureus infection
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Otitis externa
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Otitis media
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Pneumonia
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Infections and infestations
Pyelonephritis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Scrotal abscess
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Tinea corporis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
UTI
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
7.9%
6/76 • Number of events 6 • 5 years
|
|
Infections and infestations
Shingles
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Injury, poisoning and procedural complications
Ankle injury
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising of arm
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Contusion of knee
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Groin pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Head injury
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Hematoma postoperative
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Incision site pain
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Injury to hand NOS
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Intraoperative bleeding
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Laceration of finger
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Laceration of leg
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Nausea postoperative
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Postoperative bruise
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Postoperative pain
|
9.2%
7/76 • Number of events 7 • 5 years
|
|
Injury, poisoning and procedural complications
Procedural bleeding
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
7.9%
6/76 • Number of events 7 • 5 years
|
|
Injury, poisoning and procedural complications
Skull fracture NOS
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Splenic hematoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Vertebral fracture
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Ankle brachial index decreased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Blood creatinine decreased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Blood creatinine increased
|
7.9%
6/76 • Number of events 7 • 5 years
|
|
Investigations
Blood glucose increased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Blood potassium increased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Blood urea nitrogen increased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Cardiac murmur
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Creatine kinase MB high
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Creatine kinase increased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Creatinine blood increased
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Investigations
Creatinine increased
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Investigations
Decreased hemoglobin
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Hematocrit decreased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Hematocrit low
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Hemoglobin low
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Increased serum creatinine
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Investigations
Magnesium low
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Mean arterial pressure increased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Potassium increased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Raised INR
|
1.3%
1/76 • Number of events 2 • 5 years
|
|
Investigations
Raised WBC
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Sodium decreased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Systolic murmur
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
TSH decrease
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Urine output decreased
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Investigations
WBC increased
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Investigations
Weight loss
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Acidosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Gout
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyperammonemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Acute back pain
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Axillary lump
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
6/76 • Number of events 6 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Calf pain
|
1.3%
1/76 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Cervical spine degeneration
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Cervicalgia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Chronic back pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Cramp in hand
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.6%
5/76 • Number of events 5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hematoma muscle
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Lower extremities weakness of
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Rotator cuff tendinitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Skin tear
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Weakness of arms
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm NOS
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Aneurysm cerebral
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Clonus
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Dizziness
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Headache
|
7.9%
6/76 • Number of events 7 • 5 years
|
|
Nervous system disorders
Headache post-traumatic
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Hemiparesis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Lightheadedness
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Nerve pain
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Nervous system disorders
Neuropathy
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Numbness in hand
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Paresthesia lower limb
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Parkinsonism
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Positional dizziness
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Restless leg syndrome
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Sensory polyneuropathy axonal
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Nervous system disorders
Syncope
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Product Issues
Stent-graft endoleak
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Cocaine abuse
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Delirium
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Depression
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Depression worsened
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Mental status changes
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Psychiatric disorders
Mood disorder NOS
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Sleep disorder
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Acute on chronic renal failure
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Acute renal failure
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Acute renal insufficiency
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Atrophy kidney
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Bladder hypertrophy
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Bladder spasm
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Creatinine abnormal NOS
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Impaired renal function
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Kidney stone
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal artery occlusion
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal artery stenosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal cyst
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal infarct
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal infarction
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Uremia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urethral spasm
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
7.9%
6/76 • Number of events 7 • 5 years
|
|
Renal and urinary disorders
Penile bleed
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Breast inflammation
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Cervical cyst
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Scrotal edema
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Scrotal swelling
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.9%
3/76 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung mass
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.9%
3/76 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural plaque
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Singers nodules
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.9%
3/76 • Number of events 3 • 5 years
|
|
Skin and subcutaneous tissue disorders
Itching
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.9%
3/76 • Number of events 4 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash both legs
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin disorder NOS
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin red
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Arterial repair NOS
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Abdominal aortic aneurysm enlargement
|
1.3%
1/76 • Number of events 2 • 5 years
|
|
Vascular disorders
Aneurysm enlargement
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Claudication
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Vascular disorders
Essential hypertension
|
1.3%
1/76 • Number of events 2 • 5 years
|
|
Vascular disorders
Femoral artery dissection
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Hematoma
|
2.6%
2/76 • Number of events 3 • 5 years
|
|
Vascular disorders
Hypertension
|
10.5%
8/76 • Number of events 9 • 5 years
|
|
Vascular disorders
Hypertension aggravated
|
5.3%
4/76 • Number of events 4 • 5 years
|
|
Vascular disorders
Hypertension exacerbated
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypertension worsened
|
2.6%
2/76 • Number of events 2 • 5 years
|
|
Vascular disorders
Hypertensive crisis
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
9.2%
7/76 • Number of events 7 • 5 years
|
|
Vascular disorders
Iliac artery aneurysm
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Iliac artery dissection
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Leg ischemia
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Lymphocele
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Orthostatic hypotension
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Raynauds
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Refractory hypertension
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Vasovagal episode
|
1.3%
1/76 • Number of events 1 • 5 years
|
|
Vascular disorders
Venous insufficiency
|
1.3%
1/76 • Number of events 1 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place