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NCT00590798 Clinical Trial

Star-Close Early Ambulation Trial

Cardiovascular Disease Clinical Trial

— STRUT  

Official title:
Star-Close Early Ambulation Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00590798
Other study ID # STRUT
Secondary ID
Status Completed
Phase N/A
First received December 26, 2007
Last updated April 9, 2013
Start date April 2007
Est. completion date December 2008

Study information
Verified date April 2013
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Behavioral:
• Walking
Patient will walk within 30 minutes of vascular closure system procedure

Locations
Country Name City State
United States The Ohio State University Medical Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ernest Mazzaferri

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization 7 days post procedure Yes
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