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
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

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 October 20, 2014