Comparing TR Band to Statseal in Conjunction With TR Band II

Overview

The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transradial procedures. It is believed that the use of both devices in combination compared to the hemostasis band (TR band) alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that you would need to wear the hemostasis band.

This study is a physician initiated, prospective, observational, two arm, randomized study to be performed at experienced 'Radial First' centers. Patients having undergone successful radial catheterization will be enrolled in the study. Enrollment with continue at each site with an initial goal of 800 patients enrolled, with each center contributing a minimum of 50 patients. Study will be have a single interim analysis after 400 patients are enrolled for efficacy and safety and continuation of the study. Clinicians will perform the catheterization in accordance with local standard practice, with no minimum amount of anticoagulation required. Unlike the pilot trial of this device, the present study will have an identical time to first deflation of 60 minutes between the two groups, and have a larger sample size to detect any excess risk of hematoma or radial artery occlusion. The study may also help demonstrate a relatively low rate of radial artery occlusion with a rapid deflation protocol, even at lower doses of unfractionated heparin than currently recommended.