Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system for the treatment of aortic aneurysms.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms|
- Early Mortality [ Time Frame: 30 days post implant of the branch endografts ] [ Designated as safety issue: No ]The primary aim of this study is to determine the rate of early mortality after branch endograft treatment.
- Rates of Neurologic Complications/Late Branch Vessel Patency [ Time Frame: Day 0-Day 30 (Early) Day 31-1825 (Late) ] [ Designated as safety issue: No ]The secondary aims of this study are to determine the rates of neurologic complications and late branch vessel patency after branch endograft treatment, and the fractional/proportional/percent applicability/eligibility of the (standard, off-the-shelf) Zenith® t-Branch in all patients who present with thoracoabdominal aortic aneurysms
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2021|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Single Treatment Arm
All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.
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.
Study Update as of 9/3/15; 50 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524211
|Contact: Lisamarie Kernicky, RN;BSN;CCRCfirstname.lastname@example.org|
|United States, Florida|
|Boca Raton Regional Hospital (BRRH)||Recruiting|
|Boca Raton, Florida, United States, 33486|
|Contact: Lisamarie Kernicky, RN;BSN;CCRC 561-955-5239 email@example.com|
|Principal Investigator:||W. Anthony Lee, MD||Lynn Heart and Vascular Institute, Boca Raton Regional Hospital|