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
  Purpose

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


Condition Intervention
Cardiovascular Disease
Behavioral: Walking

Study Type: Interventional
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

Further study details as provided by Ohio State University:

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 ]

Enrollment: 58
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system.
Behavioral: Walking
Patient will walk within 30 minutes of vascular closure system procedure

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590798

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ernest Mazzaferri
Investigators
Principal Investigator: Earnest L Mazzaferri Jr, MD The Ohio State University Medical Center, Division of Cardiovascular Medicine
  More Information

No publications provided

Responsible Party: Ernest Mazzaferri, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00590798     History of Changes
Other Study ID Numbers: STRUT
Study First Received: December 26, 2007
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Cardiac Catheterization
Walk
Heart Catheterization
Coronary Disease
Heart Disease
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014