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Mutual agreement between FDA closed the 522 postmarket surveillance Registry.
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifeline Registry | Other | 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) |
|
| PS Registry | Other | All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AneuRx Stent Graft | Device | Abdominal Aortic Aneurysm Repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion | Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events | 5 years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medtronic Cardiovascular | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | PS Registry | All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | PS Registry |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All those treated on-label for the treatment of an AAA and followed out to 5 years. | Posted | Number | participants | 5 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Parsons | Medtronic Vascular | 707-591-2293 | angela.r.parsons@medtronic.com |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Royal Oak |
| Michigan |
| United States |
| Morristown | New Jersey | United States |
| Asheville | North Carolina | United States |
| Chapel Hill | North Carolina | United States |
| Sioux Falls | South Dakota | United States |
| Memphis | Tennessee | United States |
| Norfolk | Virginia | United States |
All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events | Study terminated before subjects met study 5 year endpoints. FDA agreed to closure of study prior to reaching the 5 year endpoint. | Posted | 5 years |
|
|
| 0 |
| 189 |
| 0 |
| 189 |
| EG001 | PS Registry | All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic | 0 | 160 | 0 | 160 |
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| D001018 |
| Aortic Diseases |