Coronary Artery DiseaseNCT04163471
VasoStat vs. TR Band for Radial Hemostasis
An observational study of Coronary Artery Disease and Peripheral Arterial Disease, run by Forge Medical at 1 site in United States.
Trial summary
VasoStat vs. TR Band compression for Radial Artery Hemostasis Following Transradial Catheterization Without Prior Radial Artery Access Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Peripheral Arterial Disease
- What is being tested?
- Radial artery mechanical compression for hemostasis
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred for diagnostic or interventional arterial catheterization procedures who have coronary artery disease or peripheral artery disease
Who may be able to join
- no prior radial access
Who cannot join
- Patients receiving concurrent investigational medications
- Cellulitis overlying radial artery
- Oral anticoagulation
- Patients receiving glycoprotein IIb/IIIa inhibitors
- Dementia
- Prisoners
Show all 9Show fewer
- Institutionalized individuals
- Allergy to medical adhesive
- Radial sheath > 6 French (ID)
Trial locations and contacts
1 site in 1 country.
United States1 site
Billings Clinic Heart and Vascular at Community Medical Center
Missoula, Montana, 59804
About this study
Official title: VasoStat vs. TR Band for Hemostasis Following Transradial Catheterization Without Prior Radial Access
VasoStat vs. TR Band compression for Radial Artery Hemostasis Following Transradial Catheterization Without Prior Radial Artery Access
Read the detailed description
Patients will be enrolled if they are scheduled to undergo a coronary or peripheral catheterization procedure involving the placement of a sheath (plastic tube) in the radial artery near the participants wrist. The purpose of this research is to compare two devices which make bleeding stop after the participants procedure is finished and the plastic tube is removed from the radial artery in the wrist. The two devices are called the VasoStat and the TR Band. Both of these devices are called hemostasis devices, which means they stop bleeding (hemostasis). Both devices are approved by the Food and Drug Administration (FDA) and are used throughout hospitals in the United States. The investigators will compare blood flow to the hand, and survey patients as to how comfortable these devices are, while they are being used to stop bleeding after the catheterization procedure.
Patients will be randomized to one device or the other as part of the study.
The investigators will noninvasively measure the blood flow to the hand by placing a soft plastic probe on the tip of the thumb called a plethysmography probe. This measurement only takes a few seconds and is painless. The investigators will measure before, after application and after removal \& before patients are discharged. Thirty days later, patients will return for another measurement and to examine the radial artery with an ultrasound probe.
40 patients will be enrolled. Statistical analysis: Based on prior studies, The investigators will assume that the VasoStat produces a 30% reduction in hand perfusion during normal clinical use. The investigators assume the TR Band produces a 70% reduction in hand perfusion during normal clinical use. Using a two-sample test of proportions, with a Type I error of 5%, a power of 80%, and an anticipated drop-out rate of 10%, The investigators will need to enroll 40 patients (20 patients in each arm of the study) (StatMate 2.0, GraphPad Software, San Diego, CA)
- Being tested
- Radial artery mechanical compression for hemostasis
- Keywords
- VasoStat, TR Band, Transradial access, Coronary angiography, Peripheral arterial disease, Coronary artery disease, Peripheral angiography, Stents
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial artery mechanical compression for hemostasisDevice
Transradial hemostasis following arterial catheterization procedures
| Study group | Role | What they receive |
|---|---|---|
| VasoStat | Randomized to use of VasoStat radial mechanical compression for hemostasis device following sheath removal after transradial access for arterial catheterization procedures. Receives: Device: Radial artery mechanical compression for hemostasis | |
| TR Band | Randomized to use of TR Band radial mechanical compression for hemostasis device following sheath removal after transradial access for arterial catheterization procedures. Receives: Device: Radial artery mechanical compression for hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of impact of two radial artery compression devices on hand perfusion measurements
Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter.
Measured: Perfusion index measurements day 1: before radial artery puncture, during wrist compression, after removal of compression device. Final perfusion index at 30-day followup appointment.
Secondary outcomes (3)
Comparison of impact of two radial artery compression devices on hand perfusion prior to and during ulnar artery compression
Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter.
Measured: Perfusion index measurements on day 1 with ulnar compression: will include before radial artery puncture, and during wrist compression after radial sheath removal.
Patient satisfaction during use of wrist compression device
Survey of patient perception of wrist discomfort, hand numbness, pain, swelling and willingness to use again in the future
Measured: During application of radial artery mechanical compression
Hand perfusion and radial artery patency after one month
Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter. Duplex ultrasound will be used to assess radial artery patency.
Measured: 30 day follow-up after use of mechanical wrist compression following transradial access for arterial catheterization procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start4 Jun 2018
- Primary completion6 Mar 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forge Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Billings Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163471
- Sponsor's protocol ID
- 20181194
- Status last verified
- Nov 2019
- First submitted
- 22 Aug 2018
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VasoStat vs. TR Band for Hemostasis Following Transradial Catheterization Without Prior Radial Access
- ClinicalTrials.gov ID
- NCT04163471
- Acronym / sponsor ID
- 20181194
- Keywords
- VasoStat, TR Band, Transradial access, Coronary angiography, Peripheral arterial disease, Coronary artery disease, Peripheral angiography, Stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Forge MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Billings Clinic
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VasoStat vs. TR Band compression for Radial Artery Hemostasis Following Transradial Catheterization Without Prior Radial Artery Access
Detailed description
Patients will be enrolled if they are scheduled to undergo a coronary or peripheral catheterization procedure involving the placement of a sheath (plastic tube) in the radial artery near the participants wrist. The purpose of this research is to compare two devices which make bleeding stop after the participants procedure is finished and the plastic tube is removed from the radial artery in the wrist. The two devices are called the VasoStat and the TR Band. Both of these devices are called hemostasis devices, which means they stop bleeding (hemostasis). Both devices are approved by the Food and Drug Administration (FDA) and are used throughout hospitals in the United States. The investigators will compare blood flow to the hand, and survey patients as to how comfortable these devices are, while they are being used to stop bleeding after the catheterization procedure.
Patients will be randomized to one device or the other as part of the study.
The investigators will noninvasively measure the blood flow to the hand by placing a soft plastic probe on the tip of the thumb called a plethysmography probe. This measurement only takes a few seconds and is painless. The investigators will measure before, after application and after removal \& before patients are discharged. Thirty days later, patients will return for another measurement and to examine the radial artery with an ultrasound probe.
40 patients will be enrolled. Statistical analysis: Based on prior studies, The investigators will assume that the VasoStat produces a 30% reduction in hand perfusion during normal clinical use. The investigators assume the TR Band produces a 70% reduction in hand perfusion during normal clinical use. Using a two-sample test of proportions, with a Type I error of 5%, a power of 80%, and an anticipated drop-out rate of 10%, The investigators will need to enroll 40 patients (20 patients in each arm of the study) (StatMate 2.0, GraphPad Software, San Diego, CA)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VasoStat | – | Device: Radial artery mechanical compression for hemostasisRandomized to use of VasoStat radial mechanical compression for hemostasis device following sheath removal after transradial access for arterial catheterization procedures. |
| TR Band | – | Device: Radial artery mechanical compression for hemostasisRandomized to use of TR Band radial mechanical compression for hemostasis device following sheath removal after transradial access for arterial catheterization procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for diagnostic or interventional arterial catheterization procedures who have coronary artery disease or peripheral artery disease
Key inclusion criteria (1 listed)
- no prior radial access
Key exclusion criteria (9 listed)
- Patients receiving concurrent investigational medications
- Cellulitis overlying radial artery
- Oral anticoagulation
- Patients receiving glycoprotein IIb/IIIa inhibitors
- Dementia
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 |
|---|---|---|
| Radial artery mechanical compression for hemostasisTransradial hemostasis following arterial catheterization procedures | Device | TR Band, VasoStat |
Primary outcome
Comparison of impact of two radial artery compression devices on hand perfusion measurements
Time frame: Perfusion index measurements day 1: before radial artery puncture, during wrist compression, after removal of compression device. Final perfusion index at 30-day followup appointment.
Changes in Hand perfusion will be quantified using a noninvasive pulse oximetry technique and a previously validated metric known as the Perfusion Index, which is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. The Perfusion Index represents a noninvasive measure of hand perfusion that can be continuously and noninvasively obtained from a specialized pulse oximeter.
3 secondary outcomes
Comparison of impact of two radial artery compression devices on hand perfusion prior to and during ulnar artery compression
Time frame: Perfusion index measurements on day 1 with ulnar compression: will include before radial artery puncture, and during wrist compression after radial sheath removal.
Patient satisfaction during use of wrist compression device
Time frame: During application of radial artery mechanical compression
Hand perfusion and radial artery patency after one month
Time frame: 30 day follow-up after use of mechanical wrist compression following transradial access for arterial catheterization procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Peripheral Arterial Disease, run by Forge Medical 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 1 inclusion and 9 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 14 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of impact of two radial artery compression devices on hand perfusion measurements (time frame: Perfusion index measurements day 1: before radial artery puncture, during wrist compression, after removal of compression device. Final perfusion index at 30-day followup appointment.). 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 14 Nov 2019.