Trial Outcomes & Findings for 34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms (NCT NCT00706394)
NCT ID: NCT00706394
Last Updated: 2021-11-01
Results Overview
Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Five years
Results posted on
2021-11-01
Participant Flow
Participant milestones
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff: Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
Baseline characteristics by cohort
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff: Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
|
Medical History
Angina
|
2 Participants
n=5 Participants
|
|
Medical History
Arrhythmia
|
6 Participants
n=5 Participants
|
|
Medical History
Cancer
|
4 Participants
n=5 Participants
|
|
Medical History
Cerebrovascular Disease
|
6 Participants
n=5 Participants
|
|
Medical History
Coagulopathy
|
1 Participants
n=5 Participants
|
|
Medical History
Congestive Heart Failure
|
3 Participants
n=5 Participants
|
|
Medical History
Coronary artery Disease
|
10 Participants
n=5 Participants
|
|
Medical History
COPD
|
11 Participants
n=5 Participants
|
|
Medical History
Diabetes
|
3 Participants
n=5 Participants
|
|
Medical History
Family History of AAA
|
3 Participants
n=5 Participants
|
|
Medical History
Gastrointestinal abnormality
|
7 Participants
n=5 Participants
|
|
Medical History
Hypertension
|
17 Participants
n=5 Participants
|
|
Medical History
Hypercholesterolemia
|
14 Participants
n=5 Participants
|
|
Medical History
Liver Disease
|
0 Participants
n=5 Participants
|
|
Medical History
Peripheral Occlusive Arterial Disease
|
9 Participants
n=5 Participants
|
|
Medical History
Prior Abdominal Surgery
|
7 Participants
n=5 Participants
|
|
Medical History
Prio MI (>6 mo)
|
1 Participants
n=5 Participants
|
|
Medical History
Prio MI (< 6 mo)
|
0 Participants
n=5 Participants
|
|
Medical History
CABG
|
3 Participants
n=5 Participants
|
|
Medical History
PTCA/Stent
|
4 Participants
n=5 Participants
|
|
Medical History
Renal Failure
|
1 Participants
n=5 Participants
|
|
Medical History
Smoking (ever)
|
19 Participants
n=5 Participants
|
|
Medical History
Valvular Disease
|
2 Participants
n=5 Participants
|
|
Medical History
Valve Replacement
|
1 Participants
n=5 Participants
|
|
Aneurysm Diameter Distribution
<30mm
|
0 Participants
n=5 Participants
|
|
Aneurysm Diameter Distribution
30mm to 39mm
|
0 Participants
n=5 Participants
|
|
Aneurysm Diameter Distribution
40mm to 49mm
|
2 Participants
n=5 Participants
|
|
Aneurysm Diameter Distribution
50mm to 59mm
|
14 Participants
n=5 Participants
|
|
Aneurysm Diameter Distribution
60mm to 69mm
|
2 Participants
n=5 Participants
|
|
Aneurysm Diameter Distribution
70mm to 79mm
|
0 Participants
n=5 Participants
|
|
Aneurysm Diameter Distribution
>79mm
|
1 Participants
n=5 Participants
|
|
Mean Aneurysm Measurements
External Iliac Diameter
|
9.3 mm
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Mean Aneurysm Measurements
Proximal non-aneurysmal neck diameter
|
28 mm
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Mean Aneurysm Measurements
Distal non-aneurysmal neck diameter
|
31 mm
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Mean Aneurysm Measurements
Maximum Aneurysm Diameter
|
57 mm
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Mean Aneurysm Measurements
Proximal non-aneurysmal right iliac diameter
|
15 mm
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Mean Aneurysm Measurements
Distal non-aneurysmal right iliac diameter
|
13 mm
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Mean Aneurysm Measurements
Proximal non-aneurysmal left iliac diameter
|
15 mm
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Mean Aneurysm Measurements
Distall non-aneurysmal left iliac diameter
|
13 mm
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Mean Aneurysm Measurements
Proximal Seal Zone lenght
|
27 mm
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Mean Aneurysm Measurements
Length Proximal Neck to Left Proximal Iliac
|
122 mm
STANDARD_DEVIATION 21 • n=5 Participants
|
|
Mean Aneurysm Measurements
Length Proximal Neck to Distal Right Iliac
|
171 mm
STANDARD_DEVIATION 23 • n=5 Participants
|
|
Mean Aneurysm Measurements
Length Proximal Neck to Distal Left Iliac
|
169 mm
STANDARD_DEVIATION 23 • n=5 Participants
|
|
Mean Aneurysm Measurements
Right Distal Seal Zone Length
|
41 mm
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Mean Aneurysm Measurements
Left Distal Seal Zone Length
|
38 mm
STANDARD_DEVIATION 13 • n=5 Participants
|
PRIMARY outcome
Timeframe: Five yearsPercentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Number of Participants With Proximal Type I Endoleak at Each Timepoint
Discharge
|
1 Participants
|
|
Number of Participants With Proximal Type I Endoleak at Each Timepoint
1 Month
|
0 Participants
|
|
Number of Participants With Proximal Type I Endoleak at Each Timepoint
6 Months
|
0 Participants
|
|
Number of Participants With Proximal Type I Endoleak at Each Timepoint
12 Months
|
0 Participants
|
|
Number of Participants With Proximal Type I Endoleak at Each Timepoint
24 Months
|
0 Participants
|
|
Number of Participants With Proximal Type I Endoleak at Each Timepoint
48 Months
|
0 Participants
|
|
Number of Participants With Proximal Type I Endoleak at Each Timepoint
60 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 MonthSuccessful delivery and deployment of the device with no complication.
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Number of Participants With Successful Delivery and Deployment of the Device
|
19 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Results are provided as the number of events over the number of patients with the follow-up image available.
Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Number of Participants With Type III Endoleaks at Each Timepoint
1 Month
|
0 Participants
|
|
Number of Participants With Type III Endoleaks at Each Timepoint
6 Months
|
0 Participants
|
|
Number of Participants With Type III Endoleaks at Each Timepoint
12 Months
|
0 Participants
|
|
Number of Participants With Type III Endoleaks at Each Timepoint
24 Months
|
0 Participants
|
|
Number of Participants With Type III Endoleaks at Each Timepoint
36 Months
|
0 Participants
|
|
Number of Participants With Type III Endoleaks at Each Timepoint
48 Months
|
0 Participants
|
|
Number of Participants With Type III Endoleaks at Each Timepoint
60 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Results are provided as the number of events over the number of patients with the follow-up image available.
Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab.
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Number of Participants With Stent Fracture at Each Timepoint
Discharge
|
0 Participants
|
|
Number of Participants With Stent Fracture at Each Timepoint
1 Month
|
0 Participants
|
|
Number of Participants With Stent Fracture at Each Timepoint
6 Months
|
0 Participants
|
|
Number of Participants With Stent Fracture at Each Timepoint
12 Months
|
0 Participants
|
|
Number of Participants With Stent Fracture at Each Timepoint
24 Months
|
0 Participants
|
|
Number of Participants With Stent Fracture at Each Timepoint
36 Months
|
0 Participants
|
|
Number of Participants With Stent Fracture at Each Timepoint
48 Months
|
0 Participants
|
|
Number of Participants With Stent Fracture at Each Timepoint
60 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Results are provided as the number of events over the number of patients with the follow-up image available.
Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab.
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Number of Participants With Stent Graft Obstruction at Each Timepoint
1 Month
|
0 Participants
|
|
Number of Participants With Stent Graft Obstruction at Each Timepoint
6 Months
|
0 Participants
|
|
Number of Participants With Stent Graft Obstruction at Each Timepoint
12 Months
|
0 Participants
|
|
Number of Participants With Stent Graft Obstruction at Each Timepoint
24 Months
|
0 Participants
|
|
Number of Participants With Stent Graft Obstruction at Each Timepoint
36 Months
|
0 Participants
|
|
Number of Participants With Stent Graft Obstruction at Each Timepoint
48 Months
|
0 Participants
|
|
Number of Participants With Stent Graft Obstruction at Each Timepoint
60 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Results are provided as the number of events over the number of patients with the follow-up image available.
Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Number of Participants With Migration at Each Timepoint
1 Month
|
0 Participants
|
|
Number of Participants With Migration at Each Timepoint
6 Months
|
0 Participants
|
|
Number of Participants With Migration at Each Timepoint
12 Months
|
0 Participants
|
|
Number of Participants With Migration at Each Timepoint
24 Months
|
0 Participants
|
|
Number of Participants With Migration at Each Timepoint
36 Months
|
0 Participants
|
|
Number of Participants With Migration at Each Timepoint
48 Months
|
0 Participants
|
|
Number of Participants With Migration at Each Timepoint
60 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Results are provided as the number of events over the number of patients with the follow-up image available.
Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Number of Participants With Type II Endoleaks at Each Timepoint
1 Month
|
4 Participants
|
|
Number of Participants With Type II Endoleaks at Each Timepoint
6 Months
|
2 Participants
|
|
Number of Participants With Type II Endoleaks at Each Timepoint
12 Months
|
0 Participants
|
|
Number of Participants With Type II Endoleaks at Each Timepoint
24 Months
|
2 Participants
|
|
Number of Participants With Type II Endoleaks at Each Timepoint
36 Months
|
1 Participants
|
|
Number of Participants With Type II Endoleaks at Each Timepoint
48 Months
|
1 Participants
|
|
Number of Participants With Type II Endoleaks at Each Timepoint
60 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Results are provided as the number of events over the number of patients with the follow-up image available.
Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab.
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
6 Months · Decrease
|
3 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
6 Months · Stable
|
11 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
6 Months · Increase
|
0 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
12 Months · Decrease
|
3 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
12 Months · Stable
|
9 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
12 Months · Increase
|
0 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
24 Months · Decrease
|
6 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
24 Months · Stable
|
10 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
24 Months · Increase
|
0 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
36 Months · Decrease
|
6 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
36 Months · Stable
|
3 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
36 Months · Increase
|
0 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
48 Months · Decrease
|
4 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
48 Months · Stable
|
3 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
48 Months · Increase
|
0 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
60 Months · Decrease
|
3 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
60 Months · Stable
|
2 Participants
|
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
60 Months · Increase
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Results are provided as the number of events over the number of patients with the follow-up image available.
Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Maximum Diameter Measurements
Pre-operative
|
56 mm
Standard Deviation 15
|
|
Maximum Diameter Measurements
1 Month
|
57 mm
Standard Deviation 15
|
|
Maximum Diameter Measurements
6 Months
|
56 mm
Standard Deviation 16
|
|
Maximum Diameter Measurements
12 Months
|
56 mm
Standard Deviation 18
|
|
Maximum Diameter Measurements
24 Months
|
52 mm
Standard Deviation 17
|
|
Maximum Diameter Measurements
36 Months
|
46 mm
Standard Deviation 8
|
|
Maximum Diameter Measurements
48 Months
|
45.5 mm
Standard Deviation 9
|
|
Maximum Diameter Measurements
60 Months
|
47.3 mm
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Results are provided as the number of events over the number of patients with the follow-up image available.
Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab.
Outcome measures
| Measure |
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy
n=19 Participants
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Aneurysm Volume Measurements
Pre-operative
|
203 cm3
Standard Deviation 125
|
|
Aneurysm Volume Measurements
1 Month
|
213 cm3
Standard Deviation 136
|
|
Aneurysm Volume Measurements
6 Months
|
217 cm3
Standard Deviation 136
|
|
Aneurysm Volume Measurements
12 Months
|
213 cm3
Standard Deviation 136
|
|
Aneurysm Volume Measurements
24 Months
|
164 cm3
Standard Deviation 49
|
|
Aneurysm Volume Measurements
36 Months
|
163 cm3
Standard Deviation 51
|
|
Aneurysm Volume Measurements
48 Months
|
166 cm3
Standard Deviation 60
|
|
Aneurysm Volume Measurements
60 Months
|
161 cm3
Standard Deviation 47
|
Adverse Events
Powerlink 34mm Cuff Stent Graft
Serious events: 14 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Powerlink 34mm Cuff Stent Graft
n=19 participants at risk
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
1/19 • Number of events 2 • Up to 5 Years
|
|
Blood and lymphatic system disorders
Decreased Hematocrit
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Cardiac disorders
Bradycardia
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Cardiac disorders
Congestive Heart Failure
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Cardiac disorders
MI
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Cardiac disorders
Triple Vessel Coronary Artery Disease
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Cholecystis
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Erosive Gastritis/Epgastric Pain
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
GI Bleeding
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Vomiting, Diarrhea, Dehydration
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Increased Ascites secondary to cirrhosis
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Lieus
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Pseudomembraneous colitis
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
General disorders
Death
|
10.5%
2/19 • Number of events 2 • Up to 5 Years
|
|
General disorders
Non cardiac CP
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
General disorders
Abdominal Pain
|
5.3%
1/19 • Number of events 2 • Up to 5 Years
|
|
Infections and infestations
Left groin incision infection
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
MRSA left lower leg
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Compression Fracture of Lumbar Spine
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Umbilical Hernia
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Tumor
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Lung cancer
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Brain tumor
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Side branch-type pancreatic papillary mucinous neoplasm
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stage IV small cell lung cancer
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left lower lung mass
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Product Issues
Endoleak with Increased aneurysm
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Product Issues
Limb extension right distal leak
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Product Issues
Type I endoleak requiring endovascular repair
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Psychiatric disorders
Major depression recurrent
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Renal and urinary disorders
Acute renal failure
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Renal and urinary disorders
Urinary retention
|
10.5%
2/19 • Number of events 2 • Up to 5 Years
|
|
Renal and urinary disorders
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
Right leg ulcer and tingling
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Surgical and medical procedures
Translumbar embolization of AAA sac
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Aneurysm increased >/=5mm
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Coagulopathy: decreased platelets due to HIT+
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Ischemic Left Leg
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Left femoral-popliteal bypass with graft
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Right femoral tibial bypass for gangrenous foot
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
Other adverse events
| Measure |
Powerlink 34mm Cuff Stent Graft
n=19 participants at risk
Powerlink 34mm cuff stent graft
Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Eye disorders
Vision problems
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Postop ileus
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
Peri rectal abscess
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
General disorders
Burning down left anterior leg
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
General disorders
Chest pain
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Mild erythema left knee
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
Right inguinal hernia
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Product Issues
Endoleak Type I distal
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Product Issues
Endoleak Type II IMA
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Product Issues
Left distal endoleak
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Product Issues
Type I endoleak
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Product Issues
Type I endoleak - placement aortic stent
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion postop
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Severe Pulmonary Enphisema
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Surgical and medical procedures
ABO Sugical Incisional Pain
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Surgical and medical procedures
Incisional pain
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Surgical and medical procedures
Left groin bleed
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Surgical and medical procedures
Removal of sternal wire - non healing
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Carotid endoarterectomy
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Carotid Stenosis
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Elevated velocity left internal carotid
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
Renal Artery stenosis
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
|
Renal and urinary disorders
Increased Creatinine
|
5.3%
1/19 • Number of events 1 • Up to 5 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60