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This is an EU protocol, and as a company, it was decided to only enroll within the US so this protocol/study is being withdrawn.
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Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints.
Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alto Abdominal Stent Graft System | Experimental | Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm. |
|
| Comparators | Active Comparator | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alto Abdominal Stent Graft System | Device | Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Freedom from Aneurysm-Related Complications (ARC) | Composite endpoint consisting of aneurysm-related death, aneurysm rupture, conversion to open surgery, type I and III endoleaks, device migration (>10mm), aneurysm sac enlargement (>5mm), occlusion, and freedom from device-related interventions | Through 5 Years |
| Neck Dilation in mm | Through 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Major Adverse Events (MAEs) | All-cause mortality, Bowel ischemia, Myocardial infarction, Paraplegia, Renal Failure, Respiratory Failure, Stroke, Index Procedural Blood Loss ≥ 1000mL | [Time Frame: At 30 days and 12 months] |
| Count of participants All Cause Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Lyden, MD | The Cleveland Clinic | Principal Investigator |
| Christopher Kwolek, MD | Newton-Wellesley Hospital | Principal Investigator |
| Hence Verhagen, MD, PhD | Erasmus University Study Center | Principal Investigator |
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Individual participant data will not be shared with others
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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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| FDA Approved EVAR AAA Graft Systems | Device | FDA approved comparator of choice |
|
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| At 30 days, 12 months, and annually up to five years |
| Count of participants AAA-related Mortality | At 30 days, 12 months, and annually up to five years |
| Number of Type Ia endoleaks | At 30 days, 12 months, and annually up to five years |
| Number of Type Ib | At 30 days, 12 months, and annually up to five years |
| Number of Type II | At 30 days, 12 months, and annually up to five years |
| Number of Type III | At 30 days, 12 months, and annually up to five years |
| Number of Type IV | At 30 days, 12 months, and annually up to five years |
| Number of Unknown Enooleaks | At 30 days, 12 months, and annually up to five years |
| Number of Secondary interventions | At 30 days, 12 months, and annually up to five years |
| Count of subjects lacking device integrity | device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak) | At 30 days, 12 months, and annually up to five years |
| Count of aneurysm ruptures | At 30 days, 12 months, and annually up to five years |
| Count of participants with conversion to open surgery | At 30 days, 12 months, and annually up to five years |
| Count of participants with type I and III endoleaks | At 30 days, 12 months, and annually up to five years |
| Count of participants with device migration (>10mm) | 12 months, and annually up to five years |
| Count of participants with aneurysm sac enlargement (>5mm) | 12 months, and annually up to five years |
| Count of subjects with occlusion | 30 days, 12 months, and annually up to five years] |
| Number of Participants with Freedom From device-related interventions | 30 days, 12 months, and annually up to five years] |
| D001018 |
| Aortic Diseases |