Trial Outcomes & Findings for Impact of Grafts and Endografts for Abdominal Aneurysms on Arterial Stiffness. (NCT NCT02642952)
NCT ID: NCT02642952
Last Updated: 2019-01-30
Results Overview
Augmentation Index corrected to 75 bpm
Recruitment status
COMPLETED
Target enrollment
52 participants
Primary outcome timeframe
Before surgery
Results posted on
2019-01-30
Participant Flow
Participant milestones
| Measure |
Open-graft Group
Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
Endograft Group
Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
30
|
|
Overall Study
COMPLETED
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Grafts and Endografts for Abdominal Aneurysms on Arterial Stiffness.
Baseline characteristics by cohort
| Measure |
Open-graft Group
n=19 Participants
Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
Endograft Group
n=25 Participants
Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.9 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
77.4 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
74.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Diameter AAA (mm)
|
54 mm
STANDARD_DEVIATION 5.1 • n=5 Participants
|
63.2 mm
STANDARD_DEVIATION 12.1 • n=7 Participants
|
59.3 mm
STANDARD_DEVIATION 10.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Before surgeryAugmentation Index corrected to 75 bpm
Outcome measures
| Measure |
Open-graft Group
n=19 Participants
Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
Endograft Group
n=25 Participants
Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
|---|---|---|
|
Aix@75
|
31.8 percentage
Standard Deviation 8.9
|
32.5 percentage
Standard Deviation 7.7
|
PRIMARY outcome
Timeframe: 2 months after SurgeryAugmentation Index corrected to 75 bpm
Outcome measures
| Measure |
Open-graft Group
n=19 Participants
Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
Endograft Group
n=25 Participants
Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
|---|---|---|
|
AIx@75
|
29.3 percentage
Standard Deviation 7.5
|
28.4 percentage
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: before surgeryOutcome measures
| Measure |
Open-graft Group
n=19 Participants
Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
Endograft Group
n=25 Participants
Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
|---|---|---|
|
Central Blood Pressure
|
120.8 mmHg
Standard Deviation 17.8
|
122.7 mmHg
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: before surgeryOutcome measures
| Measure |
Open-graft Group
n=19 Participants
Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
Endograft Group
n=25 Participants
Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
|---|---|---|
|
Carotid Radial Pulse Wave Velocity
|
7.99 cm/seg
Standard Deviation 1.44
|
8.41 cm/seg
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 2 months after surgeryOutcome measures
| Measure |
Open-graft Group
n=19 Participants
Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
Endograft Group
n=25 Participants
Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
|
|---|---|---|
|
Carotid Radial Pulse Wave Velocity
|
8.01 cm/seg
Standard Deviation 1.4
|
8.17 cm/seg
Standard Deviation 0.9
|
Adverse Events
Open-graft Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Endograft Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrés Reyes Valdivia
Ramón y Cajal University Hospital
Phone: 0034 629586239
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place