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| Name | Class |
|---|---|
| Fivos | UNKNOWN |
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This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
Evaluate the clinical performance of the AFX2 System patients against other commercially available EVAR devices and evaluate the Type III endoleak occurrence in AFX2 System patients through 5 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFX2 System | Device | The AFX2 System comprises of the following: AFX2 Bifurcated Endograft System and delivery system AFX Vela Proxmal Endograft System and delivery system AFX Stand Alone Endograft System and delivery system |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of AAA Rupture, Reintervention and Mortality | Rate of the composite of AAA rupture, aortic-related reintervention, and morality through 5 years. | 5 Years |
| Incidence of Endoleak | Cummulative incidence of Type III endoleaks at 5 years. | 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Safety | Rates of AAA rupture, aoritic-related reintervention, mortality, aneurysm related mortality, rate of imaging with CT, presence of untreated asymptomatic Type III endoleaks, occurrence of sac shrinkage, stability, and expansion >5mm in diameter, and limb occlusion at 10 years. | 10 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 20,000 patient data will be extracted from approximately 900 sites participating in the VQI EVAR registry in the US. A minimum of 2000 AFX2 System patients will be included.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Dartmouth Institute | Lebanon | New Hampshire | 03756 | United States |
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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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| D001018 |
| Aortic Diseases |