Vascular ClosureNCT00998023
Patient Comfort With Vascular Closure
A study testing Mynx Vascular Closure Device and AngioSeal Vascular Closure Device in people with Vascular Closure, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Closure
- What is being tested?
- Mynx Vascular Closure Device and AngioSeal Vascular Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vascular Closure
- Being tested
- Mynx Vascular Closure Device, AngioSeal Vascular Closure Device
- Keywords
- Angiogram, Catheter Angiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mynx Vascular Closure DeviceDevice
Also called Mynx
Comparison of two different vascular closure devices.
AngioSeal Vascular Closure DeviceDevice
Also called AngioSeal
Comparison of two different vascular closure devices.
| Study group | Role | What they receive |
|---|---|---|
| Mynx VCD | Experimental | Mynx Vascular Closure Device Receives: Device: Mynx Vascular Closure Device |
| AngioSeal VCD | Active comparator | AngioSeal Vascular Closure Device Receives: Device: AngioSeal Vascular Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately before vascular closure and immediately after vascular closure.
Secondary outcomes (1)
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
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular ClosureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Access Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- J Mocco, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998023
- Sponsor's protocol ID
- 479-2009
- Status last verified
- Nov 2011
- First submitted
- 19 Oct 2009
- Last updated
- 6 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Comfort Study With Vascular Closure: Mynx vs. Angio-Seal Evolution
- ClinicalTrials.gov ID
- NCT00998023
- Acronym / sponsor ID
- 479-2009
- Conditions
- Vascular Closure
- Keywords
- Angiogram, Catheter Angiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Access Pharmaceuticals, Inc.
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Posted 6 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mynx VCD | Experimental | Device: Mynx Vascular Closure DeviceMynx Vascular Closure Device |
| AngioSeal VCD | Active comparator | Device: AngioSeal Vascular Closure DeviceAngioSeal Vascular Closure Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mynx Vascular Closure DeviceAlso: MynxComparison of two different vascular closure devices. | Device | Mynx VCD |
| AngioSeal Vascular Closure DeviceAlso: AngioSealComparison of two different vascular closure devices. | Device | AngioSeal VCD |
Primary outcome
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).
1 secondary outcome
Major Complications
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Mocco, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mynx Vascular Closure Device and AngioSeal Vascular Closure Device in people with Vascular Closure, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score on the Visual Analogue Scale (time frame: Immediately before vascular closure and immediately after vascular closure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.