Clinical trial NCT00998023: Patient Comfort With Vascular Closure
Official title: Patient Comfort Study With Vascular Closure: Mynx vs. Angio-Seal Evolution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Closure
Keywords: Angiogram
Catheter Angiogram
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Access Pharmaceuticals, Inc.
First posted: 2009-10-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Mean Score on the Visual Analogue Scale
timeFrame: Immediately before vascular closure and immediately after vascular closure.
Secondary outcomes:
measure: Major Complications
timeFrame: 1 Day
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: J Mocco, MD
role: PRINCIPAL_INVESTIGATOR
References: