Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

NARecruitingINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

January 25, 2012

Primary Completion Date

December 31, 2031

Study Completion Date

January 31, 2032

Conditions
Thoracoabdominal Aortic AneurysmAortic Arch Aneurysm
Interventions
DEVICE

Zenith® t-Branch

The t-Branch Endovascular Graft (Zenith® t-Branch) is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for additional fixation of the device. The purpose of the branches is to allow uninterrupted blood flow to visceral vessels of the aorta. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. Although the standard Zenith t-Branch has four branches, it is anticipated that a small number of custom-made three branch devices will be included in this study for those patients in whom one of the visceral vessels is chronically thrombosed.

DEVICE

Terumo Arch Branch

The Arch Branch endograft is a custom-made endograft based on the Relay thoracic stent graft platform. The device is intended to land proximally in the ascending aorta just distal to the sinotubular junction, and distally either in the native thoracic aorta for focal arch pathologies, or more extensive pathologies either extended with another commercially available thoracic endograft or mated to a pre-existing thoracic endograft, which would serve as a distal landing zone. It is constructed of polyester graft material (same as those used for the Terumo Relay Plus or Pro) sewn to self-expanding nitinol stents with suture. The graft is fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. Additionally, the stents provide the necessary attachment and seal of the graft to the aortic wall.

Trial Locations (1)

Florida

RECRUITING

"Baptist Health South Florida, Boca Raton Regional Hospital (BRRH)"

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

William Cook Australia

INDUSTRY

collaborator

Bolton Medical

INDUSTRY

lead

Baptist Health South Florida

OTHER

NCT01524211 - Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms | Biotech Hunter | Biotech Hunter