An interventional study of AneuRx Stent Graft in Abdominal Aneurysm, sponsored by Medtronic Cardiovascular. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by Medtronic Cardiovascular · Not applicable, Interventional, and Treatment
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.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's enrollment of 349 is above the median of 72 across 462 interventional studies indexed under Aneurysm.
Browse Aneurysm studies →Medtronic Cardiovascular is the lead sponsor of 66 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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)
Device: AneuRx Stent Graft
All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
Device: AneuRx Stent Graft
Abdominal Aortic Aneurysm Repair
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
Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
Time frame: 5 years
| Milestone | Lifeline Registry | PS Registry |
|---|---|---|
| Started | 189 | 160 |
| Completed | 189 | 160 |
| Not completed | 0 | 0 |
Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion
| participants | Lifeline Registry | PS Registry |
|---|---|---|
| Death | 21 | 20 |
| Aneurysm Rupture | 0 | 1 |
| Surgical Conversion | 1 | 2 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lifeline Registry | — | 0/189 (0%) | 0/189 (0%) |
| PS Registry | — | 0/160 (0%) | 0/160 (0%) |
| Age, Continuous(years) | Lifeline Registry | PS Registry | Total |
|---|---|---|---|
| Mean | 75.1 ± 8.53 | 74.3 ± 7.31 | 75.1 ± 8.53 |
| Sex: Female, Male(Participants) | Lifeline Registry | PS Registry | Total |
|---|---|---|---|
| Female | 30 | 21 | 51 |
| Male | 159 | 139 | 298 |
| Region of Enrollment(participants) | Lifeline Registry | PS Registry | Total |
|---|---|---|---|
| United States | 189 | 160 | 349 |
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiovascular