Patient Comfort With Vascular Closure - Full Text View

Sponsor:	University of Florida
Collaborator:	Access Closure
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00998023

Purpose

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.

Condition	Intervention
Vascular Closure	Device: Mynx Vascular Closure Device Device: AngioSeal Vascular Closure Device

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Patient Comfort Study With Vascular Closure: Mynx vs. Angio-Seal Evolution

Further study details as provided by University of Florida:

Primary Outcome Measures:

Determine the amount of pain associated with device deployment. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the frequency of minor and major complications associated with each device. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	128
Study Start Date:	October 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mynx VCD: Experimental Mynx Vascular Closure Device	Device: Mynx Vascular Closure Device
AngioSeal VCD: Active Comparator AngioSeal Vascular Closure Device	Device: AngioSeal Vascular Closure Device

Detailed Description:

The traditional, standard technique of achieving femoral artery hemostasis following diagnostic and interventional catheterization procedures requires compression methods such as manual pressure or clamps held at the puncture site for 10 to 30 minutes, or even longer depending on sheath size and anticoagulation status. This traditional method can be associated with patient discomfort as well as prolonged bed rest, ambulation and hospital discharge.

Over the past decade, Vascular Closure Devices (VCDs), which include collagen hemostasis devices, percutaneous suture-mediated closure devices and metallic clips, have emerged as a novel means for reducing time to hemostasis and ambulation following catheterization procedures performed utilizing femoral arterial access. Previous studies with commercially available VCDs have shown that the reduction in time to hemostasis and time to ambulation and discharge have also led to increased patient satisfaction over manual compression.

The MynxM5 Vascular Closure Device received FDA approval on April 8, 2009. Like the Mynx 6/7F Vascular Closure Device, which received FDA approval on May 16, 2007, both are designed to achieve femoral artery hemostasis via delivery of an extravascular, water-soluble synthetic sealant which expands upon contact with subcutaneous fluids to seal the arteriotomy. In theory, the lack of pressure needed to clamp, suture, clip or cinch, which is required with intravascular closure devices, may provide an advantage in regards to increased patient comfort during closure device deployment when using the Mynx.

Although VCDs have demonstrated an increase in patient comfort and satisfaction over manual compression, little data exists regarding patient comfort when comparing different closure devices. This study is designed to evaluate patient comfort between the MynxM5 and Angio-Seal Evolution Vascular Closure Devices.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998023

Locations

United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Contact: Bree Burks, RN 352-273-7774 bree.burks@neurosurgery.ufl.edu
Principal Investigator: J Mocco, MD

Sponsors and Collaborators

University of Florida

Access Closure

Investigators

Principal Investigator:

J Mocco, MD

University of Florida

More Information

No publications provided

Responsible Party:	University of Florida ( J Mocco, MD )
Study ID Numbers:	479-2009
Study First Received:	October 19, 2009
Last Updated:	October 19, 2009
ClinicalTrials.gov Identifier:	NCT00998023 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Angiogram
Catheter Angiogram

ClinicalTrials.gov processed this record on November 20, 2009