Star-Close Early Ambulation Trial (STRUT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ernest Mazzaferri, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00590798
First received: December 26, 2007
Last updated: April 9, 2013
Last verified: April 2013

December 26, 2007
April 9, 2013
April 2007
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00590798 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Star-Close Early Ambulation Trial
Star-Close Early Ambulation Trial

To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cardiovascular Disease
Behavioral: Walking
Patient will walk within 30 minutes of vascular closure system procedure
Experimental: 1
Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system.
Intervention: Behavioral: Walking
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00590798
STRUT
No
Ernest Mazzaferri, The Ohio State University
Ernest Mazzaferri
Not Provided
Principal Investigator: Earnest L Mazzaferri Jr, MD The Ohio State University Medical Center, Division of Cardiovascular Medicine
Ohio State University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP