|
General |
Study Status |
Other |
Application Number / Requirement Number |
H080005 / PAS001 |
Date Original Protocol Accepted |
03/10/2011
|
Date Current Protocol Accepted |
01/03/2012
|
Study Name |
Elana Surgical KitHUD
|
Device Name |
ELANA ARTERIOTOMY SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Post Approval Registry
|
Study Population |
All patients selected for a procedure with the Elana Surgical Kit will be part of the registry study. This will be an 'all comers' registry with no inclusion or exclusion criteria. The registry will collect data of all device uses.
|
Sample Size |
It is expected that a site can select between 3-5 patients on an annual basis. The total expected number of sites in the USA is around 10-15. The total sample size for this registry is set at 80 device uses.
The sample size for this study was selected based on the primary endpoint. The total of 80 device uses will provide 80% power for showing the flap retention rate does not exceed 38% under the assumption that the true rate is 22%. The true flap retention rate of 22% is based on the results of an IDE study on 37 device uses.
|
Key Study Endpoints |
Primary endpoint The ability of the Elana Surgical Kit to retrieve a flap (circular disk of tissue) on the tip of the Elana Catheter while creating an arteriotomy. The flap retrieval will be judged successful, if the flap is retrieved on the tip of the Elana Catheter. The flap retrieval will be judged unsuccessful if the flap was either manually retrieved or not retrieved (= flap retention). Secondary measures Mortality and non fatal strokes will be recorded and described.
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Follow-up Visits and Length of Follow-up |
Post-operative Information will be collected pre-operatively, during the operation and one post operative follow up (>25 days) will be done.
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