Vascular Closure
Conditions
Keywords
Angiogram, Catheter Angiogram
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.
Interventions
DEVICEMynx Vascular Closure Device
Comparison of two different vascular closure devices.
DEVICEAngioSeal Vascular Closure Device
Comparison of two different vascular closure devices.
Sponsors
Access Pharmaceuticals, Inc.
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score on the Visual Analogue Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Complications | 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 |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the clinical practice of the investigator between November 2009 and July 2010.
Pre-assignment details
Participants who had any groin pain before placement of the closure device were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Mynx VCD Mynx Vascular Closure Device | 32 |
| AngioSeal VCD AngioSeal Vascular Closure Device | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Mynx VCD | AngioSeal VCD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 10 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 22 Participants | 48 Participants |
| Region of Enrollment United States | 32 participants | 32 participants | 64 participants |
| Sex: Female, Male Female | 22 Participants | 19 Participants | 41 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Mean Score on the Visual Analogue Scale
The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
Time frame: Immediately before vascular closure and immediately after vascular closure.
Population: Per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mynx VCD | Mean Score on the Visual Analogue Scale | After Closure | 2.94 Scores on a Scale | Standard Error 0.42 |
| Mynx VCD | Mean Score on the Visual Analogue Scale | Before Closure | 0.63 Scores on a Scale | Standard Error 1.01 |
| AngioSeal VCD | Mean Score on the Visual Analogue Scale | Before Closure | 0.59 Scores on a Scale | Standard Error 1.04 |
| AngioSeal VCD | Mean Score on the Visual Analogue Scale | After Closure | 5.03 Scores on a Scale | Standard Error 0.56 |
Secondary
Major Complications
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
Time frame: 1 Day
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mynx VCD | Major Complications | 0 Participants |
| AngioSeal VCD | Major Complications | 0 Participants |