Furniture Manufacturing and Management Center

Grant Detail

This is a chronological listing of grants held by this department, with the most recent listed first. New grants appear in this list weekly and contribute related to the department's Research Profile. The source of grants for this application comes directly from your institution.

04-541 Zenith Fenestrated AAA Endovascular Graft Clinical Study

Mark Farber; Peter Ford; Robert Mendes; Dianne Glover; Kimberly Kennedy

The purpose of the study is to evaluate the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of patients with abdominal aortic aneurysms (AAA) and a short infrarenal aortic neck. The Zenith® Alignment Stent is indicated for use as an adjunct to the Zenith® Fenestrated AAA Endovascular Graft to assist alignment and patency at the orifice of aortic branch vessels with diameters ranging from 3 to 8 mm. The specific aims of the study are to: 1) confirm safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft as measured by serious adverse events (SAE) and treatment success at 12 months; 2) collect information regarding device integrity, patency, clinical utility, migration, and secondary intervention. There are two hypotheses for evaluating safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft: Patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of 12-month freedom from SAE non-inferior to that of high risk patients treated with the Zenith® AAA Endovascular Graft. Null Hypothesis: The 12-month freedom from SAE for patients treated with the Zenith® Fenestrated AAA Endovascular Graft (pF) is inferior to that of high risk patients treated with the Zenith® AAA Endovascular Graft (pZ) by a margin greater than or equal to d. Ho: pZ-pF = d Alternate Hypothesis: The 12-month freedom from SAE for patients treated with the Zenith® Fenestrated AAA Endovascular Graft (pF) is non-inferior to that of high risk patients treated with the Zenith® AAA Endovascular Graft (pZ) by a margin less than d. Ha: pZ-pF < d Patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of 12-month treatment success non-inferior to that of high risk patients treated with the Zenith® AAA Endovascular Graft. Null Hypothesis: The 12-month treatment success for patients treated with the Zenith® Fenestrated AAA Endovascular Graft (pF) is inferior to that of high risk patients treated with the Zenith® AAA Endovascular Graft (pZ) by a margin greater than or equal to d. Ho: pZ-pF = d Alternate Hypothesis: The 12-month treatment success for patients treated with the Zenith® Fenestrated AAA Endovascular Graft (pF) is non-inferior to that of high risk patients treated with the Zenith® AAA Endovascular Graft (pZ) by a margin less than d. Ha: pZ-pF < d Both hypotheses will be assessed by comparing the 2.5% quantile of the Bayesian posterior distribution of ?0, where ?0 represents the effect of the Zenith® Fenestrated AAA Endovascular Graft from the Zenith® AAA Endovascular Graft at 365 days. The posterior distributions of ?0 will be that resulting from a covariate-adjusted Weibull failure-time model for the SAE hypothesis. For the treatment success hypothesis, a piecewise exponential model will be used to model the early and later portions of the survival curve. Furthermore, d is taken to be 0.10 for both hypotheses. Refer to section 1.3.6 Statistical Methods for additional details.