Star-Close Early Ambulation Trial

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

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Key information

Conditions

Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking

Behavioral

Patient will walk within 30 minutes of vascular closure system procedure

Primary outcomes

Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization

Time frame: 7 days post procedure

Sponsors and collaborators

Lead sponsor

Ernest Mazzaferri

Other

Registry information

Acronym: STRUT

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jan 11, 2008
Registry last updated: Apr 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed