|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
P070016 / PAS001 |
Date Original Protocol Accepted |
11/26/2008
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Date Current Protocol Accepted |
12/06/2011
|
Study Name |
Longterm PAS
|
Device Name |
ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
Historical Control
|
Analysis Type |
Analytical
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
This is an observational cohort of registry patients, chosen from a minimum of 15 multi-national investigative sites, with a maximum number of 25 patients enrolled at any one site.
|
Study Population |
Consecutive patients who meet the inclusion criteria and who are willing to participate will be enrolled in the study. For inclusion in the study, patients must have a descending thoracic aortic aneurysm of at least 5 cm diameter, or with a history of growth of at least 0.5 cm per year, or degenerative or atherosclerotic ulcer of at least 10 mm in depth and 20 mm in diameter, AND patient must not meet any of the general, medical or anatomical exclusion criteria.
|
Sample Size |
300 subjects, up to 50 sites Factoring in a 10% dropout rate, that adds up to 300. This will include 160 endovascular treatment patients from the pivotal clinical trial, plus an additional 125 endovascular patients, which allows for 12 patients lost to follow-up.
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Key Study Endpoints |
Aneurysm-related mortality is the primary endpoint. Additional endpoints to be assessed include device performance (change in aneurysm size, endoleaks, migration, device integrity, and secondary interventions) and morbidity.
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Follow-up Visits and Length of Follow-up |
Patients will be followed for a total of five years. Termination of follow-up will occur 30 days following explant, and upon patient withdrawal, death or closure of pre-market study.
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