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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 30, 2015