Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2010

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.

Intervention(s) in this Clinical Trial

• Device: Mynx Vascular Closure Device
• Device: AngioSeal Vascular Closure Device

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Mynx VCD
  • Mynx Vascular Closure Device
• Active Comparator: AngioSeal VCD
  • AngioSeal Vascular Closure Device

Primary Measures

• Determine the amount of pain associated with device deployment.
  • Time Frame: 6 Months
    Safety Issue?: No

Secondary Measures

• Compare the frequency of minor and major complications associated with each device.
  • Time Frame: 6 Months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Florida

Overall Clinical Trial Officials and Contacts

J Mocco, MD Principal Investigator University of Florida  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00998023

Study ID Number: 479-2009

ClinicalTrials.gov Identifier: NCT00998023

Health Authority: United States: Institutional Review Board