FLAIR™ Delivery System Study (FLAIR DS)
This study has been completed.
C. R. Bard
Information provided by:
C. R. Bard
First received: December 18, 2007
Last updated: October 20, 2010
Last verified: October 2010
The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Observational Study of the FLAIR™ Endovascular Stent Graft Optimized Delivery System|
Further study details as provided by C. R. Bard:
Primary Outcome Measures:
- Technical Success for Delivery [ Time Frame: Measured at the time of implantation (Day 0) ] [ Designated as safety issue: No ]defined as deployment of the implant to the intended location, assessed at the time of the index procedure.
Secondary Outcome Measures:
- Number of Device/Procedure-related Adverse Events(Safety of Delivery) [ Time Frame: Index Procedure to 30 days ] [ Designated as safety issue: Yes ]Device/Procedure-related adverse events from the index procedure through 30 days post procedure
|Study Start Date:||December 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
|Experimental: FLAIR Endovascular Stent Graft and Delivery System||
Device: FLAIR™ Endovascular Stent Graft
The FLAIR™ Endovascular Stent Graft is designed to treat venous anastomotic stenoses of AV access grafts, providing both structural support of the site following angioplasty (stent), and a barrier to locally recurrent flow-limiting neointimal tissue growth (covering/graft).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614315
|United States, Connecticut|
|Connecticut Image Guided Surgery|
|Fairfield, Connecticut, United States, 06825|
Sponsors and Collaborators
C. R. Bard
|Principal Investigator:||Melvin Rosenblatt, M.D.||Connecticut Image Guided Surgery|