Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
Up to 60 additional subjects may be enrolled in Continued Access phase of the study
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic abdominal aneurysm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 | Device | Endovascular aneurysm repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite measure of device technical success and procedural safety | Percent of patients with device technical success and freedom from procedural safety events in the following criteria:
| 30 days post procedure |
| Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention | Percent of patients meeting the following criteria:
| 12 months post procedure |
Not provided
Not provided
Include Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chanda Bell, RN, BSN | Contact | 765-463-7537 | 321506 | chanda.bell@cookmedical.com |
| Maria Soerensen | Contact | +45 2868 3248 | maria.soerensen@cookmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Gustavo Oderich, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham Hospital | Recruiting | Birmingham | Alabama | 35294 | United States |
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| UC San Diego | Recruiting | La Jolla | California | 92037 | United States |
|
| University of Southern California | Recruiting | Los Angeles | California | 90031 | United States |
|
| Stanford Hospitals and Clinics | Recruiting | Stanford | California | 94305 | United States |
|
| Medstar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| University of Florida Shands Hospital | Recruiting | Gainesville | Florida | 32610 | United States |
|
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
|
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Endeavor Health Cardiovascular Institute at Glenbrook Hospital | Recruiting | Glenview | Illinois | 60026 | United States |
|
| Loyola University Medical Center | Recruiting | Maywood | Illinois | 60153 | United States |
|
| Edward Hospital | Recruiting | Naperville | Illinois | 60540 | United States |
|
| Methodist Hospital of Indiana | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
|
| Massachusetts General Hospital | Completed | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| University of Massachusetts | Recruiting | Worcester | Massachusetts | 01655 | United States |
|
| University of Michigan Health System | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Barnes Jewish Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
|
| New York University Langone Medical Center | Recruiting | New York | New York | 10016 | United States |
|
| Columbia University Irving Medical Center/NY Presbyterian Hospital | Recruiting | New York | New York | 10032 | United States |
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| Holston Valley Hospital | Recruiting | Kingsport | Tennessee | 37660 | United States |
|
| Ut Southwestern | Recruiting | Dallas | Texas | 75235 | United States |
|
| Memorial Hermann Texas Medical Center/UT Health | Recruiting | Houston | Texas | 77030 | United States |
|
| Carilion Roanoke Memorial Hospital | Active, not recruiting | Roanoke | Virginia | 24014 | United States |
| St Thomas' Hospital | Active, not recruiting | London | SE1 7EH | United Kingdom |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D001018 | Aortic Diseases |
Not provided
Not provided