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Star-Close Early Ambulation Trial (STRUT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590798
First Posted: January 11, 2008
Last Update Posted: April 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ernest Mazzaferri, The Ohio State University
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Star-Close Early Ambulation Trial

Further study details as provided by Ernest Mazzaferri, The 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ernest Mazzaferri, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00590798     History of Changes
Other Study ID Numbers: STRUT
First Submitted: December 26, 2007
First Posted: January 11, 2008
Last Update Posted: April 10, 2013
Last Verified: April 2013

Keywords provided by Ernest Mazzaferri, The Ohio State University:
Cardiac Catheterization
Walk
Heart Catheterization
Coronary Disease
Heart Disease
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases