Star-Close Early Ambulation Trial - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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 ]

Estimated Enrollment:	223
Study Start Date:	April 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: No Intervention Observation of patient after Star-Close vascular closure system.

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

Contacts


Contact: Christopher D McAlhany, MD	614-293-4967	Christopher.McAlhany@osumc.edu

Contact: Luba Mazanec, RN	614-247-7733	Luba.Mazanec@ousmc.edu

Locations


United States, Ohio
	The Ohio State University Medical Center	Recruiting
	Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

Investigators


Principal Investigator:	Earnest L Mazzaferri Jr, MD	The Ohio State University Medical Center, Division of Cardiovascular Medicine

More Information

Responsible Party:	The Ohio State University Division of Cardiovascular Medicine ( Ernest Mazzaferri, Jr. MD, Assistant Professor - Clinical )
Study ID Numbers:	STRUT
First Received:	December 26, 2007
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00590798
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

Study placed in the following topic categories:

Coronary Disease

Heart Diseases

Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00590798