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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

October 19, 2009
December 5, 2011
October 2009
July 2010   (final data collection date for primary outcome measure)
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).
Determine the amount of pain associated with device deployment. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00998023 on ClinicalTrials.gov Archive Site
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
Compare the frequency of minor and major complications associated with each device. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Patient Comfort With Vascular Closure
Patient Comfort Study With Vascular Closure: Mynx vs. Angio-Seal Evolution

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vascular Closure
  • Device: Mynx Vascular Closure Device
    Comparison of two different vascular closure devices.
    Other Name: Mynx
  • Device: AngioSeal Vascular Closure Device
    Comparison of two different vascular closure devices.
    Other Name: AngioSeal
  • Experimental: Mynx VCD
    Mynx Vascular Closure Device
    Intervention: Device: Mynx Vascular Closure Device
  • Active Comparator: AngioSeal VCD
    AngioSeal Vascular Closure Device
    Intervention: Device: AngioSeal Vascular Closure Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
August 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00998023
479-2009
No
University of Florida
University of Florida
Access Pharmaceuticals, Inc.
Principal Investigator: J Mocco, MD University of Florida
University of Florida
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP