Star-Close Early Ambulation Trial (STRUT)
To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Star-Close Early Ambulation Trial|
- Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization [ Time Frame: 7 days post procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system.
Patient will walk within 30 minutes of vascular closure system procedure
To confirm that patients who receive the Star-Close vascular closure system (VCS) after diagnostic cardiac catheterization can safely ambulate within 30 minutes of catheterization.
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Earnest L Mazzaferri Jr, MD||The Ohio State University Medical Center, Division of Cardiovascular Medicine|