Patient Comfort With Vascular Closure

This study has been completed.
Sponsor:
Collaborator:
Access Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00998023
First received: October 19, 2009
Last updated: December 5, 2011
Last verified: November 2011
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
  • Mean Score on the Visual Analogue Scale [ Time Frame: Immediately before vascular closure and immediately after vascular closure. ] [ Designated as safety issue: No ]
    The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).


Secondary Outcome Measures:
  • Major Complications [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
    Number of participants with permanent access site-related nerve injury, access-site related surgical/vascular repair, amputation related to access closure complication, access site-related bleeding/hematoma requiring transfusion, any new ipsilateral lower extremity ischemia requiring non-surgical intervention, local access site-related or generalized infection requiring prolonged hospitalization or re-hospitalization and treatment with IV antibiotics or inflammatory reaction that may include local signs and drainage, treated with re-hospitalization, IV antibiotics and/or surgical intervention


Enrollment: 64
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mynx VCD
Mynx Vascular Closure Device
Device: Mynx Vascular Closure Device
Comparison of two different vascular closure devices.
Other Name: Mynx
Active Comparator: AngioSeal VCD
AngioSeal Vascular Closure Device
Device: AngioSeal Vascular Closure Device
Comparison of two different vascular closure devices.
Other Name: AngioSeal

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Access Pharmaceuticals, Inc.
Investigators
Principal Investigator: J Mocco, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00998023     History of Changes
Other Study ID Numbers: 479-2009
Study First Received: October 19, 2009
Results First Received: September 21, 2011
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Angiogram
Catheter Angiogram

ClinicalTrials.gov processed this record on August 21, 2014