Star-Close Early Ambulation Trial (STRUT)
This study has been completed.
Information provided by (Responsible Party):
Ernest Mazzaferri, The Ohio State University
First received: December 26, 2007
Last updated: April 9, 2013
Last verified: April 2013
To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Star-Close Early Ambulation Trial
Primary Outcome Measures:
- 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:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients admitted to for an outpatient left heart catheterization
- Catheterization through the femoral artery
- Able to ambulate at least 20 feet
- Able to receive the Star-Close Vascular Closure System
- Be a candidate for hospital discharge following catheterization
- Known peripheral arterial disease
- Blood pressure greater than 180/110
- Pregnant or lactating
- Anemic or low blood count
- Blood thinning medication within 5 days before catheterization
- Unable to walk 20 feet with out rest
- Complications during catheterization procedure
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00590798
|The Ohio State University Medical Center
|Columbus, Ohio, United States, 43210 |
||Earnest L Mazzaferri Jr, MD
||The Ohio State University Medical Center, Division of Cardiovascular Medicine
No publications provided
||Ernest Mazzaferri, Professor, The Ohio State University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 26, 2007
||April 9, 2013
||United States: Institutional Review Board
Keywords provided by Ohio State University:
Coronary Artery Disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014