Patient Comfort With Vascular Closure

Completed · Not applicable

Conditions studied: Vascular Closure

In brief

The purpose of this research study is to collect information on the amount of discomfort patients experience with one of two different vascular blood vessel closure devices, the MynxM5 Vascular Closure Device and the Angio-Seal Evolution Vascular Closure Device.

Key facts

Study ID

NCT00998023

Run by

University of Florida

People needed

64

Starts

2009-10-01

Expected to finish

2010-08-01

Last updated by the study team

2011-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is >18 years of age
• Patient has been informed and understands the nature of the study and provides written Informed Consent approved by the appropriate Institutional Review Board prior to enrollment
• Patient has been trained and understands the use of the 0-10 Visual Analogue Scale as an assessment of patient pain
• Patient is scheduled to undergo a diagnostic endovascular procedure involving percutaneous access through the common femoral artery

You may not qualify if…

• Per Mynx and Angio-Seal Instructions for Use
• Patient has a documented psychiatric disorder (e.g. major depression, anxiety)
• Patient has a documented chronic pain condition requiring daily treatment
• Patient carries the diagnoses of a known bleeding disorder
• Intraprocedural Exclusion Criteria: Patient has a baseline ipsilateral groin pain rating of >1 on the 0-10 Visual Analog Scale prior to closure device deployment

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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