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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 | 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Noel DeSisto | Contact | 864-270-8524 | ndesisto@endologix.com | |
| Sanjana Tabassum | Contact | stabassum@endologix.com |
| Name | Affiliation | Role |
|---|---|---|
| Sean Lyden, MD | The Cleveland Clinic | Principal Investigator |
| Christopher Kwolek, MD | Newton-Wellesley Hospital | Principal Investigator |
| Hence Verhagen, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital | Active, not recruiting | Huntsville | Alabama | 35801 | United States | |
Individual participant data will not be shared with others.
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| FDA Approved EVAR AAA Graft Systems | Device | FDA approved comparator of choice |
|
| 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 |
| Erasmus University Study Center |
| Principal Investigator |
| University of Arizona |
| Recruiting |
| Tucson |
| Arizona |
| 85716 |
| United States |
|
| Washington Regional Medical Center | Recruiting | Fayetteville | Arkansas | 72703 | United States |
|
| Central Arkansas Veterans Healthcare System | Recruiting | Little Rock | Arkansas | 72205 | United States |
|
| The Regents of the University of California, San Diego | Recruiting | La Jolla | California | 92093 | United States |
|
| Veterans Affairs San Diego Healthcare System | Recruiting | San Diego | California | 92161 | United States |
|
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20001 | United States |
|
| Jacksonville Center for Clinical Research | Recruiting | Jacksonville | Florida | 32216 | United States |
|
| Radiology and Imaging Specialists | Recruiting | Lakeland | Florida | 33801 | United States |
|
| Baptist Hospital of Miami, Miami Cardiac and Vascular Institute | Recruiting | Miami | Florida | 33176 | United States |
|
| University of Iowa Hospitals and Clinics | Active, not recruiting | Iowa City | Iowa | 52242 | United States |
| University of Louisville | Recruiting | Louisville | Kentucky | 40202-1959 | United States |
|
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
|
| Henry Ford Hospital | Withdrawn | Detroit | Michigan | 48202 | United States |
| University of Missouri | Recruiting | Columbia | Missouri | 65212 | United States |
|
| Newark Beth Israel Medical Center | Recruiting | Newark | New Jersey | 07112 | United States |
|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029-6574 | United States |
|
| Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health) | Recruiting | Staten Island | New York | 10305 | United States |
|
| The Cleveland Clinical Foundation | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| The Ohio State University | Withdrawn | Columbus | Ohio | 43210 | United States |
| Oregon Health Sciences University | Recruiting | Portland | Oregon | 97239 | United States |
|
| U.S. Department of Veterans Affairs, VA Portland Health Care System | Recruiting | Portland | Oregon | 97239 | United States |
|
| Lehigh Valley Health Network | Recruiting | Allentown | Pennsylvania | 18103 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Allegheny Health Network | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
|
| Wellmont Cardiology Services | Recruiting | Kingsport | Tennessee | 37660 | United States |
|
| The University of Texas Medical Branch at Galveston | Recruiting | Galveston | Texas | 77555 | United States |
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| Houston Methodist Research Institute | Recruiting | Houston | Texas | 77030 | United States |
|
| Sentara Hospitals | Recruiting | Norfolk | Virginia | 23507 | United States |
|
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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