Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2027

Conditions
Juxtarenal Aortic AneurysmSuprarenal Aortic AneurysmThoracoabdominal Aortic AneurysmPenetrating Aortic Ulcer
Interventions
DEVICE

Cook Custom Aortic Endograft

The Cook Custom Aortic Endograft has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.

DEVICE

Zenith t-Branch Endovascular Graft

The Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents.

DEVICE

Surgeon-Modified Endograft

The Surgeon-Modified Endografts are created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.

Trial Locations (1)

35233

RECRUITING

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
collaborator

Cook Group Incorporated

INDUSTRY

lead

University of Alabama at Birmingham

OTHER