Trial Outcomes & Findings for Endurant Evo International Clinical Trial (NCT NCT02461524)
NCT ID: NCT02461524
Last Updated: 2024-04-01
Results Overview
MAEs include the occurrence of any of the following events: All-cause mortality Bowel ischemia Myocardial infarction Paraplegia Procedural blood loss ≥1000 cc Renal failure Respiratory failure Stroke
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
30 days
Results posted on
2024-04-01
Participant Flow
Patients were screened for enrollment based on the study Inclusion/Exclusion criteria between Jun 2015 and Mar 2016.
Participant milestones
| Measure |
Endovasculair Repair
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Overall Study
STARTED
|
69
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Endovasculair Repair
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Overall Study
Death
|
16
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Device Explanted
|
5
|
|
Overall Study
Missed Visit
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Abdominal Aortic Aneurysm Endovasculair Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Age, Continuous
|
71.8 Years
STANDARD_DEVIATION 6.7 • n=69 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=69 Participants
|
|
Region of Enrollment
Netherlands
|
34 participants
n=69 Participants
|
|
Region of Enrollment
Sweden
|
9 participants
n=69 Participants
|
|
Region of Enrollment
Austria
|
5 participants
n=69 Participants
|
|
Region of Enrollment
Belgium
|
11 participants
n=69 Participants
|
|
Region of Enrollment
Denmark
|
10 participants
n=69 Participants
|
PRIMARY outcome
Timeframe: 30 daysMAEs include the occurrence of any of the following events: All-cause mortality Bowel ischemia Myocardial infarction Paraplegia Procedural blood loss ≥1000 cc Renal failure Respiratory failure Stroke
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation.
|
2 Participants
|
PRIMARY outcome
Timeframe: Index procedureTechnical success at the index procedure (as assessed intra-operatively up until closure of the access site), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure.
|
69 Participants
|
SECONDARY outcome
Timeframe: Within 30, 183, and 365 days, then annually until 5-Year post-implantationPopulation: Within 0-365 days, 69 subjects were evaluable. Within 366-731 days, 66 subject were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 days, 50 subjects were evaluable. Within 1462-1826 days, 46 subjects were evaluable.
All-cause-mortality within 30, 183, and 365 days and annually until 5 years.
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
All-cause-mortality (ACM) 0-30 Days
|
0 Participants
|
|
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
All-cause-mortality (ACM) 0-183 Days
|
2 Participants
|
|
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
All-cause-mortality (ACM) 0-365 Days
|
3 Participants
|
|
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
All-cause-mortality (ACM) 366-731 Days
|
3 Participants
|
|
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
All-cause-mortality (ACM) 732-1096 Days
|
6 Participants
|
|
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
All-cause-mortality (ACM) 1097-1461 Days
|
1 Participants
|
|
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
All-cause-mortality (ACM) 1462-1826
|
3 Participants
|
SECONDARY outcome
Timeframe: within 30, 183, and 365 days, then annually until 5-Year post-implantationPopulation: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 days, 50 subjects were evaluable. Within 1462-1826 days, 46 subjects were evaluable.
Aneurysm-related mortality within 30, 183, and 365 days, then annually until 5-Year post-implantation
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Aneurysm-related mortality (ARM) 0-30 days
|
0 Participants
|
|
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Aneurysm-related mortality (ARM) 0-183 days
|
0 Participants
|
|
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Aneurysm-related mortality (ARM) 0-365 days
|
0 Participants
|
|
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Aneurysm-related mortality (ARM) 366-731 days
|
0 Participants
|
|
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Aneurysm-related mortality (ARM) 732-1096 days
|
0 Participants
|
|
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Aneurysm-related mortality (ARM) 1097-1461 days
|
0 Participants
|
|
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Aneurysm-related mortality (ARM) 1462-1826 days
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30, 183, and 365 days, then annually until 5-Year post-implantationPopulation: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 65 subjects were evaluable. Within 732-1096 days, 57 subjects were evaluable. Note: Reporting of secondary endovascular procedures between 3 and 5 years of follow-up were only required when corresponding to adverse events related to the device, procedure, aneurysm, or subject death.
Secondary procedures to correct Type I and III endoleaks within 183 and 365 day, then annually until 5-Year post-implantation
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
0-30 Days
|
0 Participants
|
|
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
0-183 Days
|
0 Participants
|
|
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
0-365 Days
|
1 Participants
|
|
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
366-731 Days
|
0 Participants
|
|
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
732-1096 Days
|
1 Participants
|
|
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
1097-1461 Days
|
3 Participants
|
|
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
1462-1826 Days
|
1 Participants
|
SECONDARY outcome
Timeframe: within 30, 183, and 365 days, then annually until 5-Year post-implantationPopulation: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 67 subjects were evaluable. Within 366-731 days, 65 subjects were evaluable. Within 732-1096 days, 57 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable.\* Within 1462-1826 days, 46 subjects were evaluable.\* \*Reporting of events between 3 -5 years follow-up were only required when related to the device, procedure, aneurysm, or subject death
Secondary endovascular procedures within 30, 183, and 365 days, then annually until 5-Year post-implantation.
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Secondary Endovascular procedure 0-30 days
|
0 Participants
|
|
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Secondary Endovascular procedure 0-183 days
|
0 Participants
|
|
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Secondary Endovascular procedure 0-365 days
|
2 Participants
|
|
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Secondary Endovascular procedure 366-731 days
|
0 Participants
|
|
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Secondary Endovascular procedure 732-1096 days
|
4 Participants
|
|
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Secondary Endovascular procedure 1097- 1461 days
|
7 Participants
|
|
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Secondary Endovascular procedure 1462-1826 days
|
3 Participants
|
SECONDARY outcome
Timeframe: within 30, 183, and 365 days, then annually until 5-Year post-implantationPopulation: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 69 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable.\* Within 1462-1826 days, 46 subjects were evaluable.\* \*Reporting of events between 3 -5 years follow-up were only required when related to the device, procedure, aneurysm, or subject death
Serious adverse events within 30, 183, and 365 days, then annually until 5-Year post-implantation
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAE)
Serious Adverse Events (SAE) 0-30 Days
|
9 Participants
|
|
Number of Subjects With Serious Adverse Events (SAE)
Serious Adverse Events (SAE) 0-183 Days
|
19 Participants
|
|
Number of Subjects With Serious Adverse Events (SAE)
Serious Adverse Events (SAE) 0-365 Days
|
25 Participants
|
|
Number of Subjects With Serious Adverse Events (SAE)
Serious Adverse Events (SAE) 366-731 Days
|
18 Participants
|
|
Number of Subjects With Serious Adverse Events (SAE)
Serious Adverse Events (SAE) 732- 1096 Days
|
19 Participants
|
|
Number of Subjects With Serious Adverse Events (SAE)
Serious Adverse Events (SAE) 1097-1461 Days
|
12 Participants
|
|
Number of Subjects With Serious Adverse Events (SAE)
Serious Adverse Events (SAE) 1462-1826 Days
|
8 Participants
|
SECONDARY outcome
Timeframe: Within 30, 183, and 365 days, then annually until 5-Year post-implantationPopulation: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 49 subjects were evaluable. Within 1462-1826 days, 45 subjects were evaluable.
Aneurysm rupture within 30, 183, and 365 days, then annually until 5-Year post-implantation
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
The Number of Subjects With Aneurysm Rupture
Aneurysm Rupture 0-30 days
|
0 Participants
|
|
The Number of Subjects With Aneurysm Rupture
Aneurysm Rupture 0-183 days
|
0 Participants
|
|
The Number of Subjects With Aneurysm Rupture
Aneurysm Rupture 0-365 days
|
0 Participants
|
|
The Number of Subjects With Aneurysm Rupture
Aneurysm Rupture 366-731 days
|
0 Participants
|
|
The Number of Subjects With Aneurysm Rupture
Aneurysm Rupture 0732-1096 days
|
1 Participants
|
|
The Number of Subjects With Aneurysm Rupture
Aneurysm Rupture 1097-1461 days
|
1 Participants
|
|
The Number of Subjects With Aneurysm Rupture
Aneurysm Rupture 1462-1826 days
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30, 183, and 365 days, then annually until 5-Year post-implantationPopulation: Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable. Within 1462-1826 days, 45 subjects were evaluable.
Conversion to open surgery within 30, 183, and 365 days, then annually until 5-Year post-implantation
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
The Number of Subjects With Conversion to Ppen Surgery
Conversion to open surgery 0-30 days
|
0 Participants
|
|
The Number of Subjects With Conversion to Ppen Surgery
Conversion to open surgery 0-183 days
|
0 Participants
|
|
The Number of Subjects With Conversion to Ppen Surgery
Conversion to open surgery 0-365 days
|
0 Participants
|
|
The Number of Subjects With Conversion to Ppen Surgery
Conversion to open surgery 365-731 days
|
3 Participants
|
|
The Number of Subjects With Conversion to Ppen Surgery
Conversion to open surgery 732-1096 days
|
0 Participants
|
|
The Number of Subjects With Conversion to Ppen Surgery
Conversion to open surgery 1097-1461 days
|
2 Participants
|
|
The Number of Subjects With Conversion to Ppen Surgery
Conversion to open surgery 1462-1826 days
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 183, and 365 days, then annually until 5-Year post-implantationPopulation: Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 69 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable. Within 1462-1826 days, 45 subjects were evaluable.
Major adverse events within 183, and 365 days, then annually until 5-Year post-implantation
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
The Number of Subjects With Major Adverse Events (MAE)
Major Adverse Events (MAEs) 0-183 days
|
5 Participants
|
|
The Number of Subjects With Major Adverse Events (MAE)
Major Adverse Events (MAEs) 0-365 days
|
6 Participants
|
|
The Number of Subjects With Major Adverse Events (MAE)
Major Adverse Events (MAEs) 366-731 days
|
6 Participants
|
|
The Number of Subjects With Major Adverse Events (MAE)
Major Adverse Events (MAEs) 732-1096 days
|
6 Participants
|
|
The Number of Subjects With Major Adverse Events (MAE)
Major Adverse Events (MAEs) 1097-1461 days
|
7 Participants
|
|
The Number of Subjects With Major Adverse Events (MAE)
Major Adverse Events (MAEs) 1462-1826 days
|
5 Participants
|
SECONDARY outcome
Timeframe: Through 12-month, 24-month, 36-month, 48-month and 60-monthPopulation: Through 12 Months, 61 subjects were evaluable. Through 24 Months, 56 subjects were evaluable. Through 36 Months, 45 subjects were evaluable. Through 48 Months, 37 subjects were evaluable. Through 60 Months, 31 subjects were evaluable.
Stent graft migration (as compared to 1-month imaging) through 12-month, 24-month, 36-month, 48-month and 60-month using worst case.
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)
Stent Graft Migration through 12 Months
|
1 Participants
|
|
the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)
Stent Graft Migration through 24 Months
|
1 Participants
|
|
the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)
Stent Graft Migration through 36 Months
|
1 Participants
|
|
the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)
Stent Graft Migration through 48 Months
|
1 Participants
|
|
the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)
Stent Graft Migration through 60 Months
|
4 Participants
|
SECONDARY outcome
Timeframe: 12-month, 24-month, 36-month, 48-month and 60-monthPopulation: At 12 Months, 62 subjects were evaluable. At 24 Months, 57 subjects were evaluable. At 36 Months, 43 subjects were evaluable. At 48 Months, 37 subjects were evaluable. At 60 Months, 31 subjects were evaluable.
Aneurysm expansion \> 5 mm (as compared to 1-month imaging) at 12-month, 24-month, 36-month, 48-month and 60-month
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)
Aneurysm Expansion at 12 Months
|
1 Participants
|
|
Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)
Aneurysm Expansion at 24 Months
|
4 Participants
|
|
Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)
Aneurysm Expansion at 36 Months
|
6 Participants
|
|
Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)
Aneurysm Expansion at 48 Months
|
5 Participants
|
|
Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)
Aneurysm Expansion at 60 Months
|
2 Participants
|
SECONDARY outcome
Timeframe: 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-monthPopulation: At 1 Month, 66 subjects were evaluable. At 6 Months, 60 subjects were evaluable. At 12 Months, 58 subjects were evaluable. At 24 Months, 54 subjects were evaluable. At 36 Months, 40 subjects were evaluable. At 48 Months, 35 subjects were evaluable. At 60 Months, 30 subjects were evaluable.
Table will show a total number of subjects with endoleak at each follow up time point
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Number of Subject With Endoleaks Based on Imaging Findings
Participants with any type of endoleak at 1 Month
|
25 Participants
|
|
Number of Subject With Endoleaks Based on Imaging Findings
Participants with any type of endoleak at 6 Months
|
16 Participants
|
|
Number of Subject With Endoleaks Based on Imaging Findings
Participants with any type of endoleak at 12 Months
|
14 Participants
|
|
Number of Subject With Endoleaks Based on Imaging Findings
Participants with any type of endoleak at 24 Months
|
9 Participants
|
|
Number of Subject With Endoleaks Based on Imaging Findings
Participants with any type of endoleak at 36 Months
|
8 Participants
|
|
Number of Subject With Endoleaks Based on Imaging Findings
Participants with any type of endoleak at 48 Months
|
6 Participants
|
|
Number of Subject With Endoleaks Based on Imaging Findings
Participants with any type of endoleak at 60 Months
|
2 Participants
|
SECONDARY outcome
Timeframe: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-monthPopulation: Through 6 Months, 61 subjects were evaluable. Through 12 Months, 60 subjects were evaluable. Through 24 Months, 55 subjects were evaluable. Through 36 Months, 40 subjects were evaluable. Through 48 Months, 34 subjects were evaluable. Through 60 Months, 30 subjects were evaluable.
Stent graft occlusion based on imaging findings through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
Stent Graft Occlusion through 6 months
|
0 Participants
|
|
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
Stent Graft Occlusion through 12 months
|
0 Participants
|
|
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
Stent Graft Occlusion through 24 months
|
0 Participants
|
|
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
Stent Graft Occlusion through 36 months
|
0 Participants
|
|
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
Stent Graft Occlusion through 48 months
|
0 Participants
|
|
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
Stent Graft Occlusion through 60 months
|
0 Participants
|
SECONDARY outcome
Timeframe: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-monthPopulation: Through 6 Months, 61 subjects were evaluable. Through 12 Months, 65 subjects were evaluable. Through 24 Months, 61 subjects were evaluable. Through 36 Months, 57 subjects were evaluable. Through 48 Months, 55 subjects were evaluable. Through 60 Months, 51 subjects were evaluable.
Total number of subject with Any Device Deficiency through the follow up time points.
Outcome measures
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 Participants
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Number of Subject With Device Deficiencies Based on Imaging Findings
Any device deficiency through 48 months
|
36 Participants
|
|
Number of Subject With Device Deficiencies Based on Imaging Findings
Any device deficiency through 60 months
|
36 Participants
|
|
Number of Subject With Device Deficiencies Based on Imaging Findings
Any device deficiency through 6 months
|
15 Participants
|
|
Number of Subject With Device Deficiencies Based on Imaging Findings
Any device deficiency through 12 months
|
25 Participants
|
|
Number of Subject With Device Deficiencies Based on Imaging Findings
Any device deficiency through 24 months
|
33 Participants
|
|
Number of Subject With Device Deficiencies Based on Imaging Findings
Any device deficiency through 36 months
|
35 Participants
|
Adverse Events
Abdominal Aortic Aneurysm Endovascular Repair
Serious events: 54 serious events
Other events: 6 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 participants at risk
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Cardiac disorders
ANGINA UNSTABLE
|
2.9%
2/69 • Number of events 3 • 60-months
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Cardiac disorders
BRADYCARDIA
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Cardiac disorders
CARDIAC ARREST
|
4.3%
3/69 • Number of events 3 • 60-months
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Eye disorders
CATARACT
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Gastrointestinal disorders
DIVERTICULUM
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Gastrointestinal disorders
INTESTINAL POLYP
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Gastrointestinal disorders
LOCALISED INTRAABDOMINAL FLUID COLLECTION
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
General disorders
ASTHENIA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
General disorders
DEATH
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
General disorders
DEVICE DAMAGE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
General disorders
DEVICE DISLOCATION
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
General disorders
PYREXIA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
General disorders
STENT-GRAFT ENDOLEAK
|
11.6%
8/69 • Number of events 9 • 60-months
|
|
General disorders
THROMBOSIS IN DEVICE
|
2.9%
2/69 • Number of events 4 • 60-months
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Infections and infestations
BACTERIAL INFECTION
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Infections and infestations
GROIN INFECTION
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Infections and infestations
PNEUMONIA
|
4.3%
3/69 • Number of events 3 • 60-months
|
|
Infections and infestations
PNEUMONIA LEGIONELLA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Infections and infestations
UROSEPSIS
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Injury, poisoning and procedural complications
CARBON MONOXIDE POISONING
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
1.4%
1/69 • Number of events 2 • 60-months
|
|
Injury, poisoning and procedural complications
PERIPHERAL ARTERY RESTENOSIS
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Metabolism and nutrition disorders
PROPOFOL INFUSION SYNDROME
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE LEUKAEMIA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM OF RENAL PELVIS
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC SQUAMOUS CELL CARCINOMA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NASAL NEOPLASM BENIGN
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA RECURRENT
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER RECURRENT
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER METASTATIC
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECURRENT CANCER
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Nervous system disorders
CAROTID ARTERIOSCLEROSIS
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Nervous system disorders
NEUROLOGICAL SYMPTOM
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Nervous system disorders
NEUROTOXICITY
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Nervous system disorders
PARKINSON'S DISEASE
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Nervous system disorders
PETIT MAL EPILEPSY
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Psychiatric disorders
ANXIETY
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Psychiatric disorders
DEPRESSION
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.4%
1/69 • Number of events 2 • 60-months
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL HYPERTROPHY
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Vascular disorders
ANEURYSM
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Vascular disorders
AORTIC ANEURYSM RUPTURE
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Vascular disorders
HAEMORRHAGE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Vascular disorders
PERIPHERAL ARTERY STENOSIS
|
1.4%
1/69 • Number of events 1 • 60-months
|
|
Vascular disorders
PERIPHERAL ARTERY THROMBOSIS
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Vascular disorders
THROMBOSIS
|
2.9%
2/69 • Number of events 2 • 60-months
|
|
Vascular disorders
VASCULAR STENOSIS
|
1.4%
1/69 • Number of events 1 • 60-months
|
Other adverse events
| Measure |
Abdominal Aortic Aneurysm Endovascular Repair
n=69 participants at risk
Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
|
|---|---|
|
General disorders
PYREXIA
|
8.7%
6/69 • Number of events 6 • 60-months
|
Additional Information
Kristel Wittebols Sr. Clinical Research Director
Medtronic
Phone: 31 (0)43-3566566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place