| Primary | Number of Patients With Absence of Aneurysm Related Complications (ARC) | ARC is a composite of the most relevant EVAR outcomes and includes:
- Peri-Operative Death (< 30 days)
- Rupture
- Conversion to OSR
- Endoleaks; post-operative
- Migration (≥ 10mm)
- Aneurysm Enlargement (≥ 5mm)
- Endograft Limb Occlusions
- Reinterventions for device- or aneurysm-related complications
| | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | The Number of MAEs | | | Posted | | Count of Participants | | Participants | | At 30 days, 12 months, and annually up to five years | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | The Number of Participants With Aneurysm Related Complications (ARC) | ARC is a composite outcome | | Posted | | Count of Participants | | Participants | | Post 12 Months up to Five Years | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | The Number of Participants With Aneurysm Related Mortality | Death related to the aneurysm | | Posted | | Count of Participants | | Participants | | Up to Five Years | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Type Ia Endoleaks | Number of participants with Type Ia endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ia endoleak defined as persistent leak around the top of the stent graft identified during imaging surveillance at the different timepoints. | | Posted | | Count of Participants | | Participants | | Up to Five Years | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Type Ib Endoleaks | Number of participants with Type Ib endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ib endoleak defined as persistent leak around the bottom of the stent graft identified during imaging surveillance at the different timepoints. | | Posted | | Count of Participants | | Participants | | Up to Five Years | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number Endoleaks Type II | Number of participants with Type II endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type II endoleak defined as persistent blood flow into the aneurysm sac from branches of the aorta identified during imaging surveillance at the different timepoints. | | Posted | | Count of Participants | | Participants | | Up to Five Years | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Endoleaks Type IIIa | Number of participants with Type IIIa endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIa endoleak defined as persistent leak from the overlapping parts of the stent graft identified during imaging surveillance at the different timepoints. | | Posted | | Count of Participants | | Participants | | Up to Five Years | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Endoleaks Type IIIb | Number of participants with Type IIIb endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIb endoleak defined as persistent leak as a consequence of graft rupture, identified during imaging surveillance at the different timepoints. | | Posted | | Count of Participants | | Participants | | Up to Five Years | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Participants With Aneurysm Rupture | Number of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months | | Posted | | Count of Participants | | Participants | | 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Participants With Open Conversion | Number of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | | Posted | | Count of Participants | | Participants | | 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Participants With Aneurysm Expansion | Number of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months | | Posted | | Count of Participants | | Participants | | 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | | | | ID | Title | Description |
|---|
| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Patients With Endograft Occlusion | Number of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months | | Posted | | Count of Participants | | Participants | | 12 Months, 24 Months, 36 Months, 48 Months and 60 Months | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Participants With Device-Related Secondary Interventions | Number of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | | Posted | | Count of Participants | | Participants | | 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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| Secondary | Number of Patients With Adjunctive Procedures | Number of patients with adjunctive procedure during the implant | | Posted | | Count of Participants | | Participants | | Intraprocedural | | | | ID | Title | Description |
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| OG000 | AFX EVAR AAA Graft System | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | | OG001 | FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
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