Star-Close Early Ambulation Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

January 5, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00590798 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Star-Close Early Ambulation Trial

Official Title ^ICMJE

Star-Close Early Ambulation Trial

Brief Summary

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cardiovascular Disease

Intervention ^ICMJE

Behavioral: Walking

Study Arms / Comparison Groups

Experimental: Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system.
No Intervention: Observation of patient after Star-Close vascular closure system.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

223

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00590798

Responsible Party

Ernest Mazzaferri, Jr. MD, Assistant Professor - Clinical, The Ohio State University Division of Cardiovascular Medicine

Study ID Numbers ^ICMJE

STRUT

Study Sponsor ^ICMJE

Ohio State University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Earnest L Mazzaferri Jr, MD

The Ohio State University Medical Center, Division of Cardiovascular Medicine

Information Provided By

Ohio State University

Verification Date

January 2009

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