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Company business decision, IDE closed, no commercialization planned
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This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. A newly modified delivery system will provide endovascular access for implantation of a staple during endovascular graft procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endorefix | Active Comparator | Evaluation of EndoRefix Endovascular Delivery System and Staple |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoRefix | Device |
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Arko, MD | St. Paul University Hospital, Dallas Texas | Study Chair |
| Peter Faries, MD | Mount Sinai Hospital, New York | Principal Investigator |
| Louis Sanchez, MD | Barnes Jewish Hospital, St. Louis Missouri | Principal Investigator |
| Venkatash Ramaiah, MD | Arizona Heart Institute, Phoenix, Arizona | Principal Investigator |
| Mark Mewissen, MD | St. Luke's Medical Center | Principal Investigator |
| Mark Fillinger, MD | Mary Hitchcock Memorial Hospital, Lebanon New Hampshire | Principal Investigator |
| Zvonko Krajcer, MD | St. Lukes Episcopal Hospital, Houston Texas | Principal Investigator |
| Will Jordan, MD | University of Alabama, Birmingham Alabama. | Principal Investigator |
| Anthony Lee, MD | University of Florida, Gainesville, Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Arizona Heart Hospital |
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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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| Karthikes Kasirajan, MD | Emory University, Atlanta Georgia | Principal Investigator |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30368 | United States |
| Mary Hitchcock Memorial Hospital | Lebanon | New Hampshire | 03756 | United States |
| Mount Sinai Hospital | New York | New York | 10021 | United States |
| St. Paul University Hospital | Dallas | Texas | 75390 | United States |
| St. Lukes Episcopal Hospital | Houston | Texas | 77030 | United States |
| D001018 |
| Aortic Diseases |