- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00998023
Patient Comfort With Vascular Closure
Patient Comfort Study With Vascular Closure: Mynx vs. Angio-Seal Evolution
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32610
- University of Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mynx VCD
Mynx Vascular Closure Device
|
Comparison of two different vascular closure devices.
Other Names:
|
Active Comparator: AngioSeal VCD
AngioSeal Vascular Closure Device
|
Comparison of two different vascular closure devices.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Score on the Visual Analogue Scale
Time Frame: Immediately before vascular closure and immediately after vascular closure.
|
The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
|
Immediately before vascular closure and immediately after vascular closure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Complications
Time Frame: 1 Day
|
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
|
1 Day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: J Mocco, MD, University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 479-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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