Trial Outcomes & Findings for Comparison of Outcomes of Complex Abdominal Aortic Aneurysm Treatment (NCT NCT04773223)
NCT ID: NCT04773223
Last Updated: 2024-07-22
Results Overview
In open surgery this will include patients who were reoperated due to: graft infection, graft thrombosis, pseudoaneurysm formation, secondary AAA rupture. In endovascular group reintervention will include different reasons: endoleak, migration, thrombosis, infection, fracture, secondary AAA rupture.
Recruitment status
COMPLETED
Target enrollment
925 participants
Primary outcome timeframe
through study completion, an average of 7 year
Results posted on
2024-07-22
Participant Flow
Participant milestones
| Measure |
Open Surgery Group
Patients undergoing open surgery due to juxta/pararenal abdominal aortic aneurysm either using transperiotoneal or retroperitoneal approach
|
Endovascular Group
Patients undergoing some form of endovascular abdominal aortic aneurysm repair: fenestrated EVAR (FEVAR), branched EVAR (BEVAR), or combination of both
|
|---|---|---|
|
Overall Study
STARTED
|
668
|
257
|
|
Overall Study
COMPLETED
|
600
|
234
|
|
Overall Study
NOT COMPLETED
|
68
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Open Surgery Group
n=600 Participants
Patients undergoing open surgery due to juxta/pararenal abdominal aortic aneurysm using transperitonel or retroperitoneal approach.
|
Endovascular Group
n=234 Participants
Patients undergoing some form of endovascular abdominal aortic aneurysm repair: fenestrated EVAR (FEVAR), branched EVAR (BEVAR), or combination of both.
|
Total
n=834 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 7.1 • n=600 Participants
|
73 years
STANDARD_DEVIATION 6.6 • n=234 Participants
|
71.9 years
STANDARD_DEVIATION 6.9 • n=834 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=600 Participants
|
25 Participants
n=234 Participants
|
175 Participants
n=834 Participants
|
|
Sex: Female, Male
Male
|
450 Participants
n=600 Participants
|
209 Participants
n=234 Participants
|
659 Participants
n=834 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body mass index
|
26.9 kg/m2
STANDARD_DEVIATION 3.4 • n=600 Participants
|
26.7 kg/m2
STANDARD_DEVIATION 3.7 • n=234 Participants
|
26.7 kg/m2
STANDARD_DEVIATION 3.6 • n=834 Participants
|
|
Current smoker
|
170 Participants
n=600 Participants
|
89 Participants
n=234 Participants
|
259 Participants
n=834 Participants
|
|
Hypertension
|
480 Participants
n=600 Participants
|
210 Participants
n=234 Participants
|
690 Participants
n=834 Participants
|
|
Hyperlipidemia
|
413 Participants
n=600 Participants
|
144 Participants
n=234 Participants
|
557 Participants
n=834 Participants
|
|
Diabetes mellitus
|
142 Participants
n=600 Participants
|
45 Participants
n=234 Participants
|
187 Participants
n=834 Participants
|
|
Coronary artery disease
|
253 Participants
n=600 Participants
|
84 Participants
n=234 Participants
|
337 Participants
n=834 Participants
|
|
Heart failure
|
61 Participants
n=600 Participants
|
29 Participants
n=234 Participants
|
90 Participants
n=834 Participants
|
|
Atrila fibrillation
|
90 Participants
n=600 Participants
|
36 Participants
n=234 Participants
|
126 Participants
n=834 Participants
|
|
Previos stroke/transitory ischaemic attack
|
100 Participants
n=600 Participants
|
47 Participants
n=234 Participants
|
147 Participants
n=834 Participants
|
|
Carotid artery disease
|
96 Participants
n=600 Participants
|
35 Participants
n=234 Participants
|
131 Participants
n=834 Participants
|
|
Chronic obstructive pulmonary disease
|
277 Participants
n=600 Participants
|
88 Participants
n=234 Participants
|
365 Participants
n=834 Participants
|
|
Chronic kidney disease
|
167 Participants
n=600 Participants
|
62 Participants
n=234 Participants
|
229 Participants
n=834 Participants
|
|
Peripheral arterial disease
|
122 Participants
n=600 Participants
|
34 Participants
n=234 Participants
|
156 Participants
n=834 Participants
|
|
History of malignant disease
|
109 Participants
n=600 Participants
|
51 Participants
n=234 Participants
|
160 Participants
n=834 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 7 yearIn open surgery this will include patients who were reoperated due to: graft infection, graft thrombosis, pseudoaneurysm formation, secondary AAA rupture. In endovascular group reintervention will include different reasons: endoleak, migration, thrombosis, infection, fracture, secondary AAA rupture.
Outcome measures
| Measure |
Open Surgery Group
n=600 Participants
Patients undergoing open surgery due to juxta/pararenal abdominal aortic aneurysm through transperitoneal or retroperitoneal approach.
|
Endovascular Group
n=234 Participants
Patients undergoing some form of endovascular abdominal aortic aneurysm repair: fenestrated EVAR (FEVAR), branched EVAR (BEVAR), or combination of both.
|
|---|---|---|
|
Aortic Related Reintervention.
|
44 Participants
|
63 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 7 yearAny cause of mortality duing follow-up period
Outcome measures
| Measure |
Open Surgery Group
n=600 Participants
Patients undergoing open surgery due to juxta/pararenal abdominal aortic aneurysm through transperitoneal or retroperitoneal approach.
|
Endovascular Group
n=234 Participants
Patients undergoing some form of endovascular abdominal aortic aneurysm repair: fenestrated EVAR (FEVAR), branched EVAR (BEVAR), or combination of both.
|
|---|---|---|
|
All-cause Mortality
|
256 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: 30-day acute kidney injuryAcute kidney injury was defined using RIFFLE criteria.
Outcome measures
| Measure |
Open Surgery Group
n=600 Participants
Patients undergoing open surgery due to juxta/pararenal abdominal aortic aneurysm through transperitoneal or retroperitoneal approach.
|
Endovascular Group
n=234 Participants
Patients undergoing some form of endovascular abdominal aortic aneurysm repair: fenestrated EVAR (FEVAR), branched EVAR (BEVAR), or combination of both.
|
|---|---|---|
|
30-day Acute Kidney Injury
|
182 Participants
|
39 Participants
|
Adverse Events
Open Surgery Group
Serious events: 133 serious events
Other events: 0 other events
Deaths: 256 deaths
Endovascular Group
Serious events: 51 serious events
Other events: 0 other events
Deaths: 91 deaths
Serious adverse events
| Measure |
Open Surgery Group
n=600 participants at risk
Patients undergoing open surgery due to juxta/pararenal abdominal aortic aneurysm either using transperiotoneal or retroperitoneal approach
|
Endovascular Group
n=234 participants at risk
Patients undergoing some form of endovascular abdominal aortic aneurysm repair: fenestrated EVAR (FEVAR), branched EVAR (BEVAR), or combination of both
|
|---|---|---|
|
Nervous system disorders
Spinal cord ischemia
|
0.50%
3/600 • 84 monhts
|
3.4%
8/234 • 84 monhts
|
|
Vascular disorders
Acute lower limb ischemia
|
3.0%
18/600 • 84 monhts
|
3.4%
8/234 • 84 monhts
|
|
General disorders
Srugical bleeding
|
6.3%
38/600 • 84 monhts
|
5.1%
12/234 • 84 monhts
|
|
Skin and subcutaneous tissue disorders
Wound dehiscence
|
0.83%
5/600 • 84 monhts
|
0.85%
2/234 • 84 monhts
|
|
Infections and infestations
Wound infection
|
1.8%
11/600 • 84 monhts
|
2.6%
6/234 • 84 monhts
|
|
Gastrointestinal disorders
Colonic ischaemia
|
1.5%
9/600 • 84 monhts
|
1.3%
3/234 • 84 monhts
|
|
Cardiac disorders
Acute coronary syndrome
|
2.7%
16/600 • 84 monhts
|
1.3%
3/234 • 84 monhts
|
|
Nervous system disorders
Stroke or transitory ischemic attack
|
1.3%
8/600 • 84 monhts
|
0.85%
2/234 • 84 monhts
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
11/600 • 84 monhts
|
0.85%
2/234 • 84 monhts
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged intubation
|
2.3%
14/600 • 84 monhts
|
2.1%
5/234 • 84 monhts
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place