VasoStat vs. TR Band for Radial Hemostasis

Status Completed

Clinical Trial Summary

VasoStat vs. TR Band compression for Radial Artery Hemostasis Following Transradial Catheterization Without Prior Radial Artery Access

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04163471
Study type	Observational
Source	Forge Medical
Contact
Status	Completed
Phase
Start date	June 4, 2018
Completion date	May 1, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.