Abdominal Aortic Aneurysm, Thoracoabdominal Aneurysm
Conditions
Brief summary
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.
Detailed description
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.
Interventions
Endovascular exclusion of aneurysm
Sponsors
Massachusetts General Hospital
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age. 2. Not pregnant 3. Willing and able to comply with two-year follow-up period. 4. Willing and able to give informed consent prior to enrollment 5. No known allergy to stainless steel or polyester 6. No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately. 7. Life expectancy greater than two years 8. High risk candidate for open surgical repair
Exclusion criteria
see above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Aneurysm Rupture | 2 years | Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Aneurysm Repair Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair | 1,366 |
| Total | 1,366 |
Baseline characteristics
| Characteristic | Endovascular Aneurysm Repair | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1225 Participants | — |
| Age, Categorical Between 18 and 65 years | 141 Participants | — |
| Presence of abdominal or thoracoabdominal aneurysm | 1366 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 1366 participants | — |
| Sex: Female, Male Female | 315 Participants | — |
| Sex: Female, Male Male | 1051 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 775 / 1,366 |
| other Total, other adverse events | 68 / 1,366 |
| serious Total, serious adverse events | 22 / 1,366 |
Outcome results
Primary
Freedom From Aneurysm Rupture
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Aneurysm Repair | Freedom From Aneurysm Rupture | 22 Participants |