Abdominal Aneurysm
Conditions
Keywords
Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft
Brief summary
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion that has been treated in recent year via endovascular repair. The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft Systems.
Interventions
DEVICEAneuRx Stent Graft
Abdominal Aortic Aneurysm Repair
Sponsors
Medtronic
Medtronic Cardiovascular
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients implanted with an AneuRx Stent Graft per Instructions for Use * Patients must provide written informed consent and agree to be accessible for follow-up at the study center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion | 5 year | Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events | 5 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lifeline Registry All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS) | 189 |
| PS Registry All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic | 160 |
| Total | 349 |
Baseline characteristics
| Characteristic | Lifeline Registry | PS Registry | Total |
|---|---|---|---|
| Age, Continuous | 75.1 years STANDARD_DEVIATION 8.53 | 74.3 years STANDARD_DEVIATION 7.31 | 75.1 years STANDARD_DEVIATION 8.53 |
| Region of Enrollment United States | 189 participants | 160 participants | 349 participants |
| Sex: Female, Male Female | 30 Participants | 21 Participants | 51 Participants |
| Sex: Female, Male Male | 159 Participants | 139 Participants | 298 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 189 | 0 / 160 |
| serious Total, serious adverse events | 0 / 189 | 0 / 160 |
Outcome results
Primary
Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion
Time frame: 5 year
Population: All those treated on-label for the treatment of an AAA and followed out to 5 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lifeline Registry | Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion | Death | 21 participants |
| Lifeline Registry | Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion | Aneurysm Rupture | 0 participants |
| Lifeline Registry | Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion | Surgical Conversion | 1 participants |
| PS Registry | Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion | Death | 20 participants |
| PS Registry | Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion | Aneurysm Rupture | 1 participants |
| PS Registry | Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion | Surgical Conversion | 2 participants |
Secondary
Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
Time frame: 5 years
Population: Study terminated before subjects met study 5 year endpoints. FDA agreed to closure of study prior to reaching the 5 year endpoint.