Trial Outcomes & Findings for Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System (NCT NCT01348828)
NCT ID: NCT01348828
Last Updated: 2021-10-15
Results Overview
Major adverse events defined as: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss \>=1,000cc
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
30 days
Results posted on
2021-10-15
Participant Flow
Participant milestones
| Measure |
Ventana Fenestrated System
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Ventana Fenestrated System
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Overall Study
Death
|
20
|
|
Overall Study
Withdrawals/Lost to Follow-up
|
10
|
|
Overall Study
Conversion
|
2
|
|
Overall Study
missed visit
|
1
|
Baseline Characteristics
Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
Baseline characteristics by cohort
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Age, Continuous
|
72.6 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
11 participants
n=5 Participants
|
|
Region of Enrollment
France
|
9 participants
n=5 Participants
|
|
ASA Class 3 or 4
|
28 Participants
n=5 Participants
|
|
Serum Creatinine
|
1.1 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysMajor adverse events defined as: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss \>=1,000cc
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Primary Safety Endpoint
All Cause Death
|
0 events
|
|
Primary Safety Endpoint
Bowel Ischemia
|
0 events
|
|
Primary Safety Endpoint
Myocardial Infarction
|
0 events
|
|
Primary Safety Endpoint
Paraplegia
|
1 events
|
|
Primary Safety Endpoint
Procedural Blood Loss
|
7 events
|
|
Primary Safety Endpoint
Renal Failure 1 - Temp/Perm Hemodialysis
|
2 events
|
|
Primary Safety Endpoint
Renal Failure 2 - Serum Creat rise > 0.5mg/dL
|
0 events
|
|
Primary Safety Endpoint
Respiratory Failure 1 - Pneumonia
|
0 events
|
|
Primary Safety Endpoint
Stroke
|
0 events
|
SECONDARY outcome
Timeframe: 1 YearSuccessful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak. 1. Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak 2. Procedural Technical Success is defined as a subject with successful implant. 3. Aneurysm Rupture: An aneurysm is a balloon-like bulge of an artery wall. As an aneurysm grows it puts pressure on nearby structures and may eventually rupture. 4. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 5. 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). 6. 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 System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Feasibility/Effectiveness
Treatment Success
|
31 Participants
|
|
Feasibility/Effectiveness
Unsuccessful Treatment
|
18 Participants
|
|
Feasibility/Effectiveness
Procedural Technical Success
|
47 Participants
|
|
Feasibility/Effectiveness
Aneurysm Rupture
|
1 Participants
|
|
Feasibility/Effectiveness
Conversion to open repair
|
1 Participants
|
|
Feasibility/Effectiveness
Secondary Interventions
|
13 Participants
|
|
Feasibility/Effectiveness
Aneurysm Enlargement
|
3 Participants
|
|
Feasibility/Effectiveness
Clinically Significant Migration
|
1 Participants
|
|
Feasibility/Effectiveness
Type IA Endoleak
|
0 Participants
|
|
Feasibility/Effectiveness
Type IB Endoleak
|
0 Participants
|
|
Feasibility/Effectiveness
Type IIIA Endoleak
|
3 Participants
|
|
Feasibility/Effectiveness
Type IIIB Endoleak
|
2 Participants
|
SECONDARY outcome
Timeframe: Procedurally and to hospital dischargeFluoroscopy time, Renal Artery Cannulation time and procedure time
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Procedural/In-hospital Evaluations
Fluoroscopy Time
|
58 minutes
Standard Deviation 37
|
|
Procedural/In-hospital Evaluations
Renal Artery Cannulation Time
|
51 minutes
Standard Deviation 57
|
|
Procedural/In-hospital Evaluations
Total Procedure Time
|
202 minutes
Standard Deviation 72
|
SECONDARY outcome
Timeframe: Procedurally and to 5 YearsAll-cause and aneurysm-related
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Mortality
All Cause Deaths
|
20 Participants
|
|
Mortality
Aneurysm Related Deaths
|
5 Participants
|
SECONDARY outcome
Timeframe: >30 Days to 5 YearsAll-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss \>1,000cc
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Major Adverse Events
All Cause Death
|
6 Number of events
|
|
Major Adverse Events
Bowel Ischemia
|
0 Number of events
|
|
Major Adverse Events
Myocardial Infarction
|
2 Number of events
|
|
Major Adverse Events
Paraplegia
|
0 Number of events
|
|
Major Adverse Events
Procedural Blood loss
|
0 Number of events
|
|
Major Adverse Events
Renal Failure 1 - Temp/Perm Hemodialysis
|
4 Number of events
|
|
Major Adverse Events
Renal Failure 2 - Serum Creat rise >0.5mg/dL
|
1 Number of events
|
|
Major Adverse Events
Respiratory Failure 1 - Pneumonia
|
2 Number of events
|
|
Major Adverse Events
Stroke
|
0 Number of events
|
SECONDARY outcome
Timeframe: 30 Days, 6 Months and Years 1 to 5Population: All available data has been reported
Renal Dysfunction, Renal Dysfunction In subjects with baseline eGFR\>=60 and Renal Dysfunction In subjects with baseline eGFR \<60
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction-1 Month
|
4 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR >=60 - 1 Month
|
2 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR <60 - 1 Month
|
2 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction-6 Month
|
9 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR >=60 - 6 Month
|
5 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR <60 - 6 Month
|
4 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction-1 Year
|
13 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR >=60 - 1 Year
|
7 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR <60 - 1 Year
|
6 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction- 2 Year
|
7 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR >=60 - 2 Year
|
4 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR <60 - 2 Year
|
3 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction- 3 Year
|
5 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR >=60 - 3 Year
|
3 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR <60 - 3 Year
|
2 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction-4 Year
|
3 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR >=60 - 4 Year
|
2 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR <60 - 4 Year
|
1 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction- 5 Year
|
4 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR >=60 - 5 Year
|
2 Participants
|
|
Number of Participants With Renal Dysfunction
Renal Dysfunction in subjects with Baseline eGFR <60 - 5 Year
|
2 Participants
|
SECONDARY outcome
Timeframe: Procedurally and to 5 YearsPopulation: All available data has been reported
Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Aneurysm Rupture
Aneurysm rupture within 30 days
|
0 Participants
|
|
Aneurysm Rupture
Aneurysm rupture 30 days- 1 Year
|
0 Participants
|
|
Aneurysm Rupture
Aneurysm rupture 1-2 Years
|
1 Participants
|
|
Aneurysm Rupture
Aneurysm rupture 2-3 Years
|
2 Participants
|
|
Aneurysm Rupture
Aneurysm rupture 3-4 Years
|
0 Participants
|
|
Aneurysm Rupture
Aneurysm rupture 4-5 Years
|
1 Participants
|
SECONDARY outcome
Timeframe: Procedurally and to 5 YearsPopulation: All available data has been reported
Open surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations that precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Conversion to Open Repair
Open repair within 30 days
|
0 Participants
|
|
Conversion to Open Repair
Open repair 30 days - 1 Year
|
0 Participants
|
|
Conversion to Open Repair
Open repair 1 -2 Years
|
0 Participants
|
|
Conversion to Open Repair
Open repair 2 -3 Years
|
1 Participants
|
|
Conversion to Open Repair
Open repair 3-4 Years
|
1 Participants
|
|
Conversion to Open Repair
Open repair 4-5 Years
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 Days, 6 Months, and Years 1 to 5Population: All data has been entered
Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Device Integrity
Device Migration - 6 Month
|
1 Participants
|
|
Device Integrity
Ventana Stent Fracture - 1 Month
|
0 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
|
1 Participants
|
|
Device Integrity
Left Renal Stent Fracture - 6 Month
|
2 Participants
|
|
Device Integrity
Right Renal Stent Fracture - 6 Month
|
3 Participants
|
|
Device Integrity
Stent Kinking/Compression - 6 Month
|
1 Participants
|
|
Device Integrity
Device Migration - 1 Year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture - 1 Year
|
3 Participants
|
|
Device Integrity
Left Renal Stent Fracture - 1 Year
|
2 Participants
|
|
Device Integrity
Right Renal Stent Fracture - 1 Year
|
3 Participants
|
|
Device Integrity
Stent Kinking/Compression - 1 Year
|
0 Participants
|
|
Device Integrity
Device Migration - 2 Year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture - 2 Year
|
3 Participants
|
|
Device Integrity
Left Renal Stent Fracture - 2 Year
|
2 Participants
|
|
Device Integrity
Right Renal Stent Fracture - 2 Year
|
5 Participants
|
|
Device Integrity
Stent Kinking/Compression - 2 Year
|
2 Participants
|
|
Device Integrity
Device Migration - 3 Year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture - 3 Year
|
4 Participants
|
|
Device Integrity
Left Renal Stent Fracture - 3 Year
|
1 Participants
|
|
Device Integrity
Right Renal Stent Fracture - 3 Year
|
2 Participants
|
|
Device Integrity
Stent Kinking/Compression - 3 Year
|
0 Participants
|
|
Device Integrity
Device Migration - 4 Year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture - 4 Year
|
4 Participants
|
|
Device Integrity
Left Renal Stent Fracture - 4 Year
|
2 Participants
|
|
Device Integrity
Right Renal Stent Fracture - 4 Year
|
2 Participants
|
|
Device Integrity
Stent Kinking/Compression - 4 Year
|
0 Participants
|
|
Device Integrity
Device Migration - 5 Year
|
0 Participants
|
|
Device Integrity
Ventana Stent Fracture - 5 Year
|
4 Participants
|
|
Device Integrity
Left Renal Stent Fracture - 5 Year
|
1 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, 6 Months, and Years 1 to 5Population: All available data has been entered.
Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Stent Graft Patency
Ventana and Bifurcated occlusion - 1 Month
|
0 Participants
|
|
Stent Graft Patency
LRA Occlusion - 1 Month
|
0 Participants
|
|
Stent Graft Patency
RRA Occlusion - 1 Month
|
0 Participants
|
|
Stent Graft Patency
Ventana and Bifurcated Occlusion - 6 Month
|
0 Participants
|
|
Stent Graft Patency
LRA Occlusion - 6 Month
|
1 Participants
|
|
Stent Graft Patency
RRA Occlusion - 6 Month
|
1 Participants
|
|
Stent Graft Patency
Ventana and Bifurcated occlusion - 1 Year
|
1 Participants
|
|
Stent Graft Patency
LRA Occlusion - 1 Year
|
1 Participants
|
|
Stent Graft Patency
RRA Occlusion - 1 Year
|
1 Participants
|
|
Stent Graft Patency
Ventana and Bifurcated occlusion - 2 Year
|
1 Participants
|
|
Stent Graft Patency
LRA Occlusion - 2 Year
|
4 Participants
|
|
Stent Graft Patency
RRA Occlusion - 2 Year
|
1 Participants
|
|
Stent Graft Patency
Ventana and Bifurcated occlusion - 3 Year
|
0 Participants
|
|
Stent Graft Patency
LRA Occlusion - 3 Year
|
1 Participants
|
|
Stent Graft Patency
RRA Occlusion - 3 Year
|
0 Participants
|
|
Stent Graft Patency
Ventana and Bifurcated occlusion - 4 Year
|
0 Participants
|
|
Stent Graft Patency
LRA Occlusion - 4 Year
|
1 Participants
|
|
Stent Graft Patency
RRA Occlusion - 4 Year
|
0 Participants
|
|
Stent Graft Patency
Ventana and Bifurcated occlusion - 5 Year
|
0 Participants
|
|
Stent Graft Patency
LRA Occlusion - 5 Year
|
2 Participants
|
|
Stent Graft Patency
RRA Occlusion - 5 Year
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 Months, and Years 1 to 5Population: All data has been entered
Change in aneurysm sac diameter - decrease \> 5mm, Increase \> 5mm, Stable (+/- 5mm) and No growth.
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Aneurysm Diameter Change
Decrease (>5mm)- 6 Month
|
4 Participants
|
|
Aneurysm Diameter Change
Increase (>5mm) - 6 Month
|
1 Participants
|
|
Aneurysm Diameter Change
Stable (±5mm) - 6 Month
|
34 Participants
|
|
Aneurysm Diameter Change
No Growth - 6 Month
|
38 Participants
|
|
Aneurysm Diameter Change
Decrease (>5mm)- 1 Year
|
7 Participants
|
|
Aneurysm Diameter Change
Increase (>5mm) - 1 Year
|
0 Participants
|
|
Aneurysm Diameter Change
Stable (±5mm) - 1 Year
|
28 Participants
|
|
Aneurysm Diameter Change
No Growth - 1 Year
|
35 Participants
|
|
Aneurysm Diameter Change
Decrease (>5mm)- 2 Year
|
9 Participants
|
|
Aneurysm Diameter Change
Increase (>5mm) - 2 Year
|
8 Participants
|
|
Aneurysm Diameter Change
Stable (±5mm) - 2 Year
|
18 Participants
|
|
Aneurysm Diameter Change
No Growth - 2 Year
|
27 Participants
|
|
Aneurysm Diameter Change
Decrease (>5mm)- 3 Year
|
8 Participants
|
|
Aneurysm Diameter Change
Increase (>5mm) - 3 Year
|
1 Participants
|
|
Aneurysm Diameter Change
Stable (±5mm) - 3 Year
|
13 Participants
|
|
Aneurysm Diameter Change
No Growth - 3 Year
|
21 Participants
|
|
Aneurysm Diameter Change
Decrease (>5mm)- 4 Year
|
6 Participants
|
|
Aneurysm Diameter Change
Increase (>5mm) - 4 Year
|
0 Participants
|
|
Aneurysm Diameter Change
Stable (±5mm) - 4 Year
|
10 Participants
|
|
Aneurysm Diameter Change
No Growth - 4 Year
|
16 Participants
|
|
Aneurysm Diameter Change
Decrease (>5mm)- 5 Year
|
4 Participants
|
|
Aneurysm Diameter Change
Increase (>5mm) - 5 Year
|
4 Participants
|
|
Aneurysm Diameter Change
Stable (±5mm) - 5 Year
|
5 Participants
|
|
Aneurysm Diameter Change
No Growth - 5 Year
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 Days, 6 Month and Years 1 to 5Population: All data has been entered
Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak (device-related: Type I (proximal or distal), Type III, Type IV; non-device related: Type II), device migration, or other device defect.
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Secondary Procedures
Aortic Occlusion -Bypass - Other- 1 Year
|
0 Participants
|
|
Secondary Procedures
Aortic Occlusion -Bypass - Other- 2 Year
|
1 Participants
|
|
Secondary Procedures
Aortic Occlusion -Bypass - Other- 3 Year
|
0 Participants
|
|
Secondary Procedures
Aortic Revision - 6 Month
|
1 Participants
|
|
Secondary Procedures
Aortic Revision - 1 Year
|
1 Participants
|
|
Secondary Procedures
Aortic Revision - 2 Year
|
1 Participants
|
|
Secondary Procedures
Iliac Extension - 4 Year
|
0 Participants
|
|
Secondary Procedures
Iliac Extension - 5 Year
|
1 Participants
|
|
Secondary Procedures
Renal Stenting - 30 Days
|
0 Participants
|
|
Secondary Procedures
Aneurysm Expansion - Conversion to open repair - 30 days
|
0 Participants
|
|
Secondary Procedures
Aneurysm Expansion - Conversion to open repair - 6 Month
|
0 Participants
|
|
Secondary Procedures
Aneurysm Expansion - Conversion to open repair - 1 Year
|
0 Participants
|
|
Secondary Procedures
Aneurysm Expansion - Conversion to open repair - 2 Year
|
0 Participants
|
|
Secondary Procedures
Aneurysm Expansion - Conversion to open repair - 3 Year
|
0 Participants
|
|
Secondary Procedures
Aneurysm Expansion - Conversion to open repair - 4 Year
|
1 Participants
|
|
Secondary Procedures
Aneurysm Expansion - Conversion to open repair - 5 Year
|
0 Participants
|
|
Secondary Procedures
Aneurysm Rupture - Conversion to open repair - 30 days
|
0 Participants
|
|
Secondary Procedures
Aneurysm Rupture - Conversion to open repair - 6 Month
|
0 Participants
|
|
Secondary Procedures
Aneurysm Rupture - Conversion to open repair - 1 Year
|
0 Participants
|
|
Secondary Procedures
Aneurysm Rupture - Conversion to open repair - 2 Year
|
1 Participants
|
|
Secondary Procedures
Aneurysm Rupture - Conversion to open repair - 3 Year
|
0 Participants
|
|
Secondary Procedures
Aneurysm Rupture - Conversion to open repair - 4 Year
|
0 Participants
|
|
Secondary Procedures
Aneurysm Rupture - Conversion to open repair - 5 Year
|
0 Participants
|
|
Secondary Procedures
Aortic Occlusion -Bypass - Other- 30 Days
|
0 Participants
|
|
Secondary Procedures
Aortic Occlusion -Bypass - Other- 6 Month
|
0 Participants
|
|
Secondary Procedures
Aortic Occlusion -Bypass - Other- 4 Year
|
0 Participants
|
|
Secondary Procedures
Aortic Occlusion -Bypass - Other- 5 Year
|
0 Participants
|
|
Secondary Procedures
Device Migration - Renal Stenting - 30 Days
|
0 Participants
|
|
Secondary Procedures
Device Migration - Renal Stenting - 6 Month
|
0 Participants
|
|
Secondary Procedures
Device Migration - Renal Stenting - 1 Year
|
0 Participants
|
|
Secondary Procedures
Device Migration - Renal Stenting - 2 Year
|
1 Participants
|
|
Secondary Procedures
Device Migration - Renal Stenting - 3 Year
|
0 Participants
|
|
Secondary Procedures
Device Migration - Renal Stenting 4 Year
|
0 Participants
|
|
Secondary Procedures
Device Migration - Renal Stenting - 5 Year
|
0 Participants
|
|
Secondary Procedures
Iliac Artery Stenosis/Occlusion - 30 Days
|
2 Participants
|
|
Secondary Procedures
Iliac Artery Stenosis/Occlusion - 6 Month
|
1 Participants
|
|
Secondary Procedures
Iliac Artery Stenosis/Occlusion - 1 Year
|
3 Participants
|
|
Secondary Procedures
Iliac Artery Stenosis/Occlusion - 2 Year
|
0 Participants
|
|
Secondary Procedures
Iliac Artery Stenosis/Occlusion - 3 Year
|
0 Participants
|
|
Secondary Procedures
Iliac Artery Stenosis/Occlusion - 4 Year
|
0 Participants
|
|
Secondary Procedures
Iliac Artery Stenosis/Occlusion - 5 Year
|
0 Participants
|
|
Secondary Procedures
Renal Artery Stenosis/Occlusion - 30 Days
|
0 Participants
|
|
Secondary Procedures
Renal Artery Stenosis/Occlusion - 6 Month
|
9 Participants
|
|
Secondary Procedures
Renal Artery Stenosis/Occlusion - 1 Year
|
9 Participants
|
|
Secondary Procedures
Renal Artery Stenosis/Occlusion - 2 Year
|
2 Participants
|
|
Secondary Procedures
Renal Artery Stenosis/Occlusion - 3 Year
|
0 Participants
|
|
Secondary Procedures
Renal Artery Stenosis/Occlusion - 4 Year
|
0 Participants
|
|
Secondary Procedures
Renal Artery Stenosis/Occlusion - 5 Year
|
0 Participants
|
|
Secondary Procedures
SMA Artery Occlusion- 30 Days
|
1 Participants
|
|
Secondary Procedures
SMA Artery Occlusion- 6 Month
|
0 Participants
|
|
Secondary Procedures
SMA Artery Occlusion- 1 Year
|
1 Participants
|
|
Secondary Procedures
SMA Artery Occlusion- 2 Year
|
0 Participants
|
|
Secondary Procedures
SMA Artery Occlusion- 3 Year
|
0 Participants
|
|
Secondary Procedures
SMA Artery Occlusion- 4 Year
|
0 Participants
|
|
Secondary Procedures
SMA Artery Occlusion- 5 Year
|
0 Participants
|
|
Secondary Procedures
Stent Fracture - 30 Days
|
0 Participants
|
|
Secondary Procedures
Stent Fracture - 6 Month
|
0 Participants
|
|
Secondary Procedures
Stent Fracture - 1 Year
|
0 Participants
|
|
Secondary Procedures
Stent Fracture - 2 Year
|
1 Participants
|
|
Secondary Procedures
Stent Fracture - 3 Year
|
2 Participants
|
|
Secondary Procedures
Stent Fracture - 4 Year
|
1 Participants
|
|
Secondary Procedures
Stent Fracture - 5 Year
|
0 Participants
|
|
Secondary Procedures
Stent Migration - 30 Days
|
0 Participants
|
|
Secondary Procedures
Stent Migration - 6 Month
|
0 Participants
|
|
Secondary Procedures
Stent Migration - 1 Year
|
0 Participants
|
|
Secondary Procedures
Stent Migration - 2 Year
|
0 Participants
|
|
Secondary Procedures
Stent Migration - 3 Year
|
0 Participants
|
|
Secondary Procedures
Stent Migration - 4 Year
|
0 Participants
|
|
Secondary Procedures
Stent Migration - 5 Year
|
1 Participants
|
|
Secondary Procedures
Type IA Endoleak - 30 Days
|
0 Participants
|
|
Secondary Procedures
Type IA Endoleak - 6 Month
|
1 Participants
|
|
Secondary Procedures
Type IA Endoleak - 1 Year
|
1 Participants
|
|
Secondary Procedures
Type IA Endoleak - 2 Year
|
0 Participants
|
|
Secondary Procedures
Type IA Endoleak - 3 Year
|
0 Participants
|
|
Secondary Procedures
Type IA Endoleak - 4 Year
|
0 Participants
|
|
Secondary Procedures
Type IA Endoleak - 5 Year
|
0 Participants
|
|
Secondary Procedures
Liquid Embolization - 30 Days
|
0 Participants
|
|
Secondary Procedures
Liquid Embolization - 6 Month
|
1 Participants
|
|
Secondary Procedures
Liquid Embolization - 1 Year
|
1 Participants
|
|
Secondary Procedures
Liquid Embolization - 2 Year
|
0 Participants
|
|
Secondary Procedures
Liquid Embolization - 3 Year
|
0 Participants
|
|
Secondary Procedures
Liquid Embolization - 4 Year
|
0 Participants
|
|
Secondary Procedures
Liquid Embolization - 5 Year
|
0 Participants
|
|
Secondary Procedures
Type IB Endoleak - 30 Days
|
0 Participants
|
|
Secondary Procedures
Type IB Endoleak - 6 Month
|
0 Participants
|
|
Secondary Procedures
Type IB Endoleak - 1 Year
|
0 Participants
|
|
Secondary Procedures
Type IB Endoleak - 2 Year
|
0 Participants
|
|
Secondary Procedures
Type IB Endoleak - 3 Year
|
1 Participants
|
|
Secondary Procedures
Type IB Endoleak - 4 Year
|
0 Participants
|
|
Secondary Procedures
Type IB Endoleak - 5 Year
|
0 Participants
|
|
Secondary Procedures
Conversion to Open Repair - 30 Days
|
0 Participants
|
|
Secondary Procedures
Conversion to Open Repair - 6 Month
|
0 Participants
|
|
Secondary Procedures
Conversion to Open Repair - 1 Year
|
0 Participants
|
|
Secondary Procedures
Conversion to Open Repair - 2 Year
|
0 Participants
|
|
Secondary Procedures
Conversion to Open Repair - 3 Year
|
1 Participants
|
|
Secondary Procedures
Conversion to Open Repair - 4 Year
|
0 Participants
|
|
Secondary Procedures
Conversion to Open Repair - 5 Year
|
0 Participants
|
|
Secondary Procedures
Type II Endoleak - 30 Days
|
0 Participants
|
|
Secondary Procedures
Type II Endoleak - 6 Month
|
0 Participants
|
|
Secondary Procedures
Type II Endoleak - 1 Year
|
0 Participants
|
|
Secondary Procedures
Type II Endoleak - 2 Year
|
1 Participants
|
|
Secondary Procedures
Type II Endoleak - 3 Year
|
1 Participants
|
|
Secondary Procedures
Type II Endoleak - 4 Year
|
0 Participants
|
|
Secondary Procedures
Type II Endoleak - 5 Year
|
0 Participants
|
|
Secondary Procedures
Coil Embolization - 30 Days
|
0 Participants
|
|
Secondary Procedures
Coil Embolization - 6 Month
|
0 Participants
|
|
Secondary Procedures
Coil Embolization - 1 Year
|
0 Participants
|
|
Secondary Procedures
Coil Embolization - 2 Year
|
1 Participants
|
|
Secondary Procedures
Coil Embolization - 3 Year
|
1 Participants
|
|
Secondary Procedures
Coil Embolization - 4 Year
|
0 Participants
|
|
Secondary Procedures
Coil Embolization - 5 Year
|
0 Participants
|
|
Secondary Procedures
Type III Endoleak - 30 Days
|
1 Participants
|
|
Secondary Procedures
Type III Endoleak - 6 Month
|
1 Participants
|
|
Secondary Procedures
Type III Endoleak - 1 Year
|
2 Participants
|
|
Secondary Procedures
Type III Endoleak - 2 Year
|
2 Participants
|
|
Secondary Procedures
Type III Endoleak - 3 Year
|
4 Participants
|
|
Secondary Procedures
Type III Endoleak - 4 Year
|
0 Participants
|
|
Secondary Procedures
Type III Endoleak - 5 Year
|
1 Participants
|
|
Secondary Procedures
Aortic Extension- 30 Days
|
0 Participants
|
|
Secondary Procedures
Aortic Extension- 6 Month
|
0 Participants
|
|
Secondary Procedures
Aortic Extension- 1 Year
|
0 Participants
|
|
Secondary Procedures
Aortic Extension- 2 Year
|
1 Participants
|
|
Secondary Procedures
Aortic Extension- 3 Year
|
2 Participants
|
|
Secondary Procedures
Aortic Extension- 4 Year
|
0 Participants
|
|
Secondary Procedures
Aortic Extension- 5 Year
|
0 Participants
|
|
Secondary Procedures
Aortic Revision - 30 Days
|
0 Participants
|
|
Secondary Procedures
Aortic Revision - 3 Year
|
2 Participants
|
|
Secondary Procedures
Aortic Revision - 4 Year
|
0 Participants
|
|
Secondary Procedures
Aortic Revision - 5 Year
|
1 Participants
|
|
Secondary Procedures
Balloon Angioplasty - 30 Days
|
1 Participants
|
|
Secondary Procedures
Balloon Angioplasty - 6 Month
|
0 Participants
|
|
Secondary Procedures
Balloon Angioplasty - 1 Year
|
1 Participants
|
|
Secondary Procedures
Balloon Angioplasty - 2 Year
|
0 Participants
|
|
Secondary Procedures
Balloon Angioplasty - 3 Year
|
0 Participants
|
|
Secondary Procedures
Balloon Angioplasty - 4 Year
|
0 Participants
|
|
Secondary Procedures
Balloon Angioplasty - 5 Year
|
0 Participants
|
|
Secondary Procedures
Iliac Extension - 30 Days
|
0 Participants
|
|
Secondary Procedures
Iliac Extension - 6 Month
|
0 Participants
|
|
Secondary Procedures
Iliac Extension - 1 Year
|
0 Participants
|
|
Secondary Procedures
Iliac Extension - 2 Year
|
0 Participants
|
|
Secondary Procedures
Iliac Extension - 3 Year
|
0 Participants
|
|
Secondary Procedures
Renal Stenting - 6 Month
|
0 Participants
|
|
Secondary Procedures
Renal Stenting - 1 Year
|
0 Participants
|
|
Secondary Procedures
Renal Stenting - 2 Year
|
1 Participants
|
|
Secondary Procedures
Renal Stenting - 3 Year
|
1 Participants
|
|
Secondary Procedures
Renal Stenting - 4 Year
|
0 Participants
|
|
Secondary Procedures
Renal Stenting - 5 Year
|
0 Participants
|
SECONDARY outcome
Timeframe: Procedurally and to hospital dischargeContrast volume and estimated blood loss
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Procedural/In-hospital Evaluations
Contrast Volume
|
205 mL
Standard Deviation 107
|
|
Procedural/In-hospital Evaluations
Blood Loss
|
581 mL
Standard Deviation 396
|
SECONDARY outcome
Timeframe: DischargeTime to hospital discharge
Outcome measures
| Measure |
Ventana Fenestrated System
n=49 Participants
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Procedural/In-hospital Evaluations
|
5 days
Standard Deviation 4
|
Adverse Events
Ventana Fenestrated System
Serious events: 42 serious events
Other events: 46 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Ventana Fenestrated System
n=49 participants at risk
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Angina pectoris
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Atrial fibrillation
|
8.2%
4/49 • Number of events 4 • 5 Years
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Cardiac failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Cardiac ischemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
6.1%
3/49 • Number of events 4 • 5 Years
|
|
Cardiac disorders
Congestive heart failure
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Cardiac disorders
Coronary artery occlusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Decompensation cardiac
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Diastolic heart failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Heart failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Unstable angina
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Gastrointestinal disorders
Bowel ischemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Diverticulum intestinal hemorrhagic
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Hematemesis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Small bowel obstruction
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Arterial stent occlusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Catheter site hematoma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Chest pain
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Complication of device insertion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Device dislocation
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
General disorders
Device fracture
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Device misdeployment
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Endoleak
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Fever
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Multi organ failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Multiple organ failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Stent dislodgement
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Stent occlusion
|
10.2%
5/49 • Number of events 5 • 5 Years
|
|
General disorders
Stent strut fracture
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
General disorders
Stent-graft compression
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Stent-graft endoleak type IA
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Stent-graft endoleak type IB
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
General disorders
Stent-graft endoleak type II
|
8.2%
4/49 • Number of events 4 • 5 Years
|
|
General disorders
Stent-graft endoleak type III
|
16.3%
8/49 • Number of events 8 • 5 Years
|
|
General disorders
Stent-graft malfunction
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Stent-graft separation
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Weakness
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Acute on chronic bronchitis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Catheter related infection
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Diarrhea, Clostridium difficile
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Endocarditis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Graft infection
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Lower respiratory tract infection
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Pneumonia
|
14.3%
7/49 • Number of events 7 • 5 Years
|
|
Infections and infestations
Post procedural site wound infection
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Staphylococcus aureus bacteraemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Staphylococcus epidermidis septicemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Urosepsis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Injury, poisoning and procedural complications
Intraoperative bleeding
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Investigations
Angiogram
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Investigations
Increased serum creatinine
|
6.1%
3/49 • Number of events 3 • 5 Years
|
|
Investigations
Vascular imaging
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Loin pain
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in hip
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma lung stage IV
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder carcinoma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowel cancer
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain tumor
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer of lung
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer of lung stage IV
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal carcinoma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Cerebral hemorrhage
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Dementia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Ischemic stroke
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Metabolic encephalopathy
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Stroke
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Thalamic infarction
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Psychiatric disorders
Delirium
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Acute renal failure
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
Anuria
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Bilateral renal artery stenosis
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Chronic renal failure worsened
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
End stage renal failure
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
Function kidney decreased
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Kidney dysfunction
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal artery occlusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal artery stenosis
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal impairment
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal insufficiency
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute on chronic respiratory failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
4.1%
2/49 • Number of events 4 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
Surgical and medical procedures
Hip arthroplasty
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Surgical and medical procedures
Intravenous fluids replacement
|
2.0%
1/49 • Number of events 3 • 5 Years
|
|
Surgical and medical procedures
Stent removal
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Surgical and medical procedures
Surgical intervention
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
Vascular disorders
Abdominal aneurysm, ruptured
|
6.1%
3/49 • Number of events 3 • 5 Years
|
|
Vascular disorders
Abdominal aortic aneurysm enlargement
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Aneurysm enlargement
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Aneurysm ruptured
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Aortic occlusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Arterial bleeding
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Arteriovenous fistula
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Arteriovenous graft site stenosis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Femoral artery dissection
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Femoral artery thrombosis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Hypertension
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Vascular disorders
Iliac artery occlusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Iliac artery rupture
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Iliac artery stenosis
|
4.1%
2/49 • Number of events 2 • 5 Years
|
Other adverse events
| Measure |
Ventana Fenestrated System
n=49 participants at risk
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.3%
8/49 • Number of events 8 • 5 Years
|
|
Blood and lymphatic system disorders
Anemia aggravated
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
Cardiac disorders
Acute decompensated heart failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Atrial tachycardia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Cardiac disorders
Congestive heart failure
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Cardiac disorders
Coronary artery disease aggravated
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Heart failure
|
6.1%
3/49 • Number of events 3 • 5 Years
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Myocardial ischemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Eye disorders
Cataract
|
4.1%
2/49 • Number of events 4 • 5 Years
|
|
Eye disorders
Visual acuity decreased
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Gastrointestinal disorders
Bowel ischemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Constipation
|
6.1%
3/49 • Number of events 4 • 5 Years
|
|
Gastrointestinal disorders
Distended abdomen
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Rectal bleeding
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Gastrointestinal disorders
Stomach ulcer with hemorrhage
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Ankle edema
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Arterial stent occlusion
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
General disorders
Cardiac pacemaker malfunction
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Catheter site hematoma
|
8.2%
4/49 • Number of events 4 • 5 Years
|
|
General disorders
Catheter site swelling
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Complication of device insertion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Debility
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
General malaise
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Hernia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Implant site seroma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Shivering
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Stent occlusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Stent strut fracture
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Stent-graft angulation
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
General disorders
Stent-graft endoleak type II
|
12.2%
6/49 • Number of events 6 • 5 Years
|
|
General disorders
Stent-graft endoleak type III
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
General disorders
Stent-graft malfunction
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
General disorders
Stent-graft material failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Bronchitis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Diverticulitis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Groin infection
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Infected epidermal cyst
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Infected hydrocele
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Laryngitis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Lung infection
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Sepsis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Infections and infestations
Urinary infection
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Contusion of shoulder region
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Delirium on emergence
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Incision site complication
|
2.0%
1/49 • Number of events 2 • 5 Years
|
|
Injury, poisoning and procedural complications
Incision site pain
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Intraoperative bleeding
|
8.2%
4/49 • Number of events 4 • 5 Years
|
|
Injury, poisoning and procedural complications
Seroma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Injury, poisoning and procedural complications
Subcutaneous hematoma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Investigations
Blood creatinine increased
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Investigations
Blood pressure increased
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Investigations
Cardiac monitoring
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Investigations
Creatinine increased
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Investigations
Creatinine serum increased
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Investigations
INR increased
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Investigations
Increased blood pressure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Investigations
Increased serum creatinine
|
8.2%
4/49 • Number of events 4 • 5 Years
|
|
Investigations
Serum creatinine increased
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Metabolism and nutrition disorders
Diabetes mellitus loss of control
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Metabolism and nutrition disorders
Worsening of diabetes
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Acute back pain
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Ankle swelling
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Hip arthrosis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Lower extremities weakness of
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in thigh
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Trochanteric bursitis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Larynx carcinoma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Abnormal sensation of limbs
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Carotid occlusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dementia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Numbness
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Numbness in leg
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Palsy Bells
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Upper limb paresis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Psychiatric disorders
Confusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Acute on chronic renal failure
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Chronic renal failure worsened
|
2.0%
1/49 • Number of events 3 • 5 Years
|
|
Renal and urinary disorders
Function kidney decreased
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal artery dissection
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
Renal artery occlusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal artery stenosis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal impairment
|
6.1%
3/49 • Number of events 3 • 5 Years
|
|
Renal and urinary disorders
Renal infarct
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal infarction
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Urinary tract disorder
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
2.0%
1/49 • Number of events 3 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Wheeze
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Itching
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Surgical and medical procedures
Blood transfusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Abdominal aortic aneurysm enlargement
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Vascular disorders
Aneurysm enlargement
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Blue toe syndrome
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Claudication
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Vascular disorders
Groin hematoma
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Vascular disorders
Hematoma
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Hypertension
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Vascular disorders
Hypertension worsened
|
4.1%
2/49 • Number of events 2 • 5 Years
|
|
Vascular disorders
Hypotension
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Iliac artery occlusion
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Intermittent claudication
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Popliteal artery aneurysm
|
2.0%
1/49 • Number of events 1 • 5 Years
|
|
Vascular disorders
Superficial femoral arterial stenosis
|
2.0%
1/49 • Number of events 1 • 5 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place