Clinical trial NCT04163471: VasoStat vs. TR Band for Radial Hemostasis
Official title: VasoStat vs. TR Band for Hemostasis Following Transradial Catheterization Without Prior Radial Access
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Peripheral Arterial Disease
Keywords: VasoStat
TR Band
Transradial access
Coronary angiography
Peripheral arterial disease
Coronary artery disease
Peripheral angiography
Stents
Lead sponsor: Forge Medical
Sponsor class: INDUSTRY
Collaborators: name: Billings Clinic
First posted: 2019-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred for diagnostic or interventional arterial catheterization procedures who have coronary artery disease or peripheral artery disease

Brief summary: 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)

Eligibility criteria: Inclusion Criteria:

• no prior radial access

Exclusion Criteria:

* Patients receiving concurrent investigational medications
* Cellulitis overlying radial artery
* Oral anticoagulation
* Patients receiving glycoprotein IIb/IIIa inhibitors
* Dementia
* Prisoners
* Institutionalized individuals
* Allergy to medical adhesive
* Radial sheath \> 6 French (ID)

Primary outcomes:
measure: Comparison of impact of two radial artery compression devices on hand perfusion measurements
timeFrame: 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:
measure: Comparison of impact of two radial artery compression devices on hand perfusion prior to and during ulnar artery compression
timeFrame: Perfusion index measurements on day 1 with ulnar compression: will include before radial artery puncture, and during wrist compression after radial sheath removal.
measure: Patient satisfaction during use of wrist compression device
timeFrame: During application of radial artery mechanical compression
measure: Hand perfusion and radial artery patency after one month
timeFrame: 30 day follow-up after use of mechanical wrist compression following transradial access for arterial catheterization procedures
Other outcomes:
measure: Adverse outcomes
timeFrame: During index hospital visit and at 30 day follow-up
Locations:
city: Missoula
country: United States
facility: Billings Clinic Heart and Vascular at Community Medical Center
state: Montana
Study officials:
References: