Trial Outcomes & Findings for Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts (NCT NCT00583050)
NCT ID: NCT00583050
Last Updated: 2020-05-08
Results Overview
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1366 participants
Primary outcome timeframe
2 years
Results posted on
2020-05-08
Participant Flow
Participant milestones
| Measure |
Endovascular Aneurysm Repair
Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
|
|---|---|
|
Overall Study
STARTED
|
1366
|
|
Overall Study
COMPLETED
|
1366
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Endovascular Aneurysm Repair
n=1366 Participants
Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1366 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
141 Participants
n=1366 Participants
|
|
Age, Categorical
>=65 years
|
1225 Participants
n=1366 Participants
|
|
Sex: Female, Male
Female
|
315 Participants
n=1366 Participants
|
|
Sex: Female, Male
Male
|
1051 Participants
n=1366 Participants
|
|
Region of Enrollment
United States
|
1366 participants
n=1366 Participants
|
|
Presence of abdominal or thoracoabdominal aneurysm
|
1366 Participants
n=1366 Participants
|
PRIMARY outcome
Timeframe: 2 yearsAbsence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Outcome measures
| Measure |
Endovascular Aneurysm Repair
n=1366 Participants
Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
|
|---|---|
|
Freedom From Aneurysm Rupture
|
22 Participants
|
Adverse Events
Endovascular Aneurysm Repair
Serious events: 22 serious events
Other events: 68 other events
Deaths: 775 deaths
Serious adverse events
| Measure |
Endovascular Aneurysm Repair
n=1366 participants at risk
Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
|
|---|---|
|
Vascular disorders
Aneurysm Rupture
|
1.6%
22/1366 • 2 years
|
Other adverse events
| Measure |
Endovascular Aneurysm Repair
n=1366 participants at risk
Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
|
|---|---|
|
Vascular disorders
Aneurysm size increase
|
5.0%
68/1366 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place