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The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| p-Branch® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| p-Branch® | Device | Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations. | Within 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Farber, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Methodist Hospital of Indiana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33706000 | Derived | Attaran RR, Bhalla A, Mena-Hurtado CI, Ochoa Chaar CI. Correlation between great saphenous length of treatment zone and diameter with improvement in symptoms after ablation. J Vasc Surg Venous Lymphat Disord. 2021 Nov;9(6):1443-1450. doi: 10.1016/j.jvsv.2021.02.013. Epub 2021 Mar 9. | |
| 31255472 | Derived | Farber MA, Oderich GS, Timaran C, Sanchez LA, Dawson Z; Zenith p-Branch Feasibility Study Investigators. Results from a prospective multicenter feasibility study of Zenith p-Branch stent graft. J Vasc Surg. 2019 Nov;70(5):1409-1418.e3. doi: 10.1016/j.jvs.2019.03.026. Epub 2019 Jun 27. |
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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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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Community Heart and Vascular Hospital | Indianapolis | Indiana | 46250 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Mercy Hospital | St Louis | Missouri | 63141 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| 28216359 | Derived | Timaran DE, Knowles M, Ali T, Timaran CH. Fenestrated endovascular aneurysm repair among octogenarians at high and standard risk for open repair. J Vasc Surg. 2017 Aug;66(2):354-359. doi: 10.1016/j.jvs.2016.11.064. Epub 2017 Feb 16. |
| D001018 |
| Aortic Diseases |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |